Handling Compliance - Mpje

1. Identify the correct action if a stock bottle label is torn and the lot number cannot be verified.

   Quarantine the product and do not dispense; replace stock only if identity is confirmed. Quarantining prevents distribution of potentially misidentified products, ensuring traceability and compliance with labeling laws.

2. What is the correct action if a sterile compounded preparation is found without a beyond-use date label?

   Quarantine and do not dispense until properly labeled (or discard if uncertain). Quarantining ensures patient safety by preventing use of preparations with unknown stability or expiration.

3. What must a controlled substance inventory record include for Schedule II drugs regarding quantity?

   Exact count for Schedule II. Precise quantification is required for high-risk substances to maintain strict accountability and prevent diversion.

4. What is the required frequency for the federal controlled substance inventory after the initial inventory?

   At least every 2 years (biennial inventory). Biennial inventories ensure ongoing accountability and detection of discrepancies in controlled substance stocks.

5. What additional notation is required on a controlled substance inventory regarding timing of the count?

   Indicate whether inventory was taken at opening or closing of business. This notation provides context for the inventory timing, aiding in accurate record-keeping and regulatory compliance.

6. What is the required primary engineering control for sterile hazardous drug compounding?

   Biological safety cabinet (Class II) or compounding aseptic containment isolator. These controls provide containment and ventilation to prevent contamination during sterile hazardous drug preparation.

7. Identify the correct action if a Schedule II shipment arrives with a missing bottle compared with the invoice.

   Report discrepancy to supplier promptly and document; investigate as potential loss. Prompt reporting and documentation help identify potential theft or errors, complying with DEA diversion prevention protocols.

8. What is the federal inventory timing requirement when a pharmacy first engages in controlled substances?

   Initial inventory on the date controlled substances are first handled. DEA requires an initial count to establish a baseline for accountability when beginning controlled substance activities.

9. Which storage rule must be met for Schedule II controlled substances in a pharmacy?

   Locked safe/cabinet or dispersed throughout noncontrolled stock. Federal law mandates secure storage to restrict access and reduce theft or diversion risks in pharmacies.

10. Which option is required to prevent contamination when repackaging oral solid dosage forms?

    Use clean equipment, avoid cross-contact, and label with drug name, strength, lot, and BUD. These practices maintain product integrity and traceability, complying with FDA guidelines to avoid contamination or misbranding.

11. What is the required DEA Form number used to order Schedule II controlled substances?

    DEA Form 222. Federal regulations require this form to ensure secure ordering and tracking of highly controlled substances, minimizing diversion risks.

12. How long must controlled substance records generally be maintained under federal law?

    At least 2 years. Retention for this period allows for audits and investigations, supporting compliance and diversion prevention.

13. What is the correct handling requirement for refrigerated drugs to prevent loss of potency and misbranding?

    Maintain labeled temperature range with documented monitoring; quarantine excursions. Proper temperature control preserves drug efficacy, with monitoring and quarantine preventing dispensing of compromised products.

14. What is the required DEA form used to report theft or significant loss of controlled substances?

    DEA Form 106. This form is mandated by the DEA to promptly report incidents, enabling investigation and prevention of diversion.

15. What is the required DEA form used to request permission to destroy controlled substances?

    DEA Form 41. DEA requires this form for authorization to destroy controlled substances, ensuring proper documentation and diversion prevention.

16. What is the required DEA form used to surrender a DEA registration (voluntary surrender)?

    DEA Form 104. This form facilitates voluntary relinquishment of registration, maintaining regulatory oversight and preventing unauthorized handling.

17. Which dispensing requirement helps prevent diversion when a controlled substance prescription is partially filled?

    Document quantity dispensed and quantity remaining on the prescription record. Tracking quantities ensures the total does not exceed the prescribed amount, preventing overuse or diversion.

18. What is the correct handling for expired controlled substances awaiting reverse distribution to prevent diversion?

    Segregate and secure in a controlled-access area until transferred/destroyed. Segregation prevents accidental dispensing or access, maintaining security until proper disposal or return.

19. What quantity standard is permitted on inventory for Schedule III–V controlled substances?

    Estimated count unless container holds more than $1{,}000$ dosage units. Estimation is allowed for efficiency in lower-risk schedules, with exact counts required for large quantities to ensure accuracy.

20. What does "readily retrievable" mean for controlled substance records in a non-separate filing system?

    Identifiable at time of inspection by a distinct mark (for example, red "C"). Marking enables efficient identification during audits, ensuring records are accessible without separate filing.

21. Which rule applies to Schedule III–V controlled substances regarding storage in a pharmacy?

    Store securely to deter theft; no federal safe requirement. DEA regulations emphasize security without mandating a safe to balance accessibility and diversion prevention for lower-risk substances.

22. Which labeling element is essential to prevent misbranding when dispensing a prescription medication?

    Patient name, prescriber, directions, drug name/strength, quantity, and pharmacy info. These elements are required under federal law to ensure accurate identification and safe use, avoiding misbranding violations.

23. Which option best prevents contamination when handling nonsterile hazardous drugs in the pharmacy?

    Use appropriate PPE and designated containment area per USP <800>. USP <800> standards mandate protective measures to minimize exposure risks and ensure safe handling of hazardous drugs.

24. What is the required DEA form used to register for controlled substance handling privileges?

    DEA Form 224. Pharmacies must use this form to obtain authorization for handling controlled substances, ensuring compliance with federal law.

25. What is the required separation rule for Schedule II records versus Schedule III–V records?

    Schedule II records separate; Schedule III–V separate or readily retrievable. Separation ensures quick access during inspections, facilitating compliance verification and reducing errors.

Study these flashcards