Controlled Recordkeeping - Mpje

1. What two inventory time-of-day options are permitted, and what must be recorded about that choice?

   Opening or close of business; record which was used. DEA allows inventory at opening or closing of business for flexibility, requiring notation of the choice for consistency and verification.

2. Find the compliance status: A pharmacy can retrieve controlled substance records in 5 business days. Is this readily retrievable?

   No; readily retrievable requires retrieval within 2 business days. DEA's definition of readily retrievable for central records requires access within 2 business days, so 5 days fails compliance.

3. Which document serves as the required record for receipt of Schedule $III$–$V$ controlled substances?

   Invoice/packing document retained as the receipt record. Invoices or packing slips serve as official receipt records for Schedule $III$–$V$ to verify acquisitions.

4. What does "readily retrievable" mean for controlled substance records in a pharmacy setting?

   Retrievable from other records within 2 business days. In pharmacy settings, DEA defines readily retrievable as the ability to produce records within 2 business days for inspection purposes.

5. Identify the correct inventory method: A Schedule $II$ bottle contains 2,500 tablets. May the count be estimated?

   No; Schedule $II$ requires an exact count. Schedule $II$ inventories always require exact counts to maintain strict accountability.

6. Which DEA form is used to record theft or significant loss of controlled substances?

   DEA Form 106. DEA Form 106 is specifically designated for reporting theft or significant loss to notify authorities promptly.

7. What is the recordkeeping requirement for a controlled substance theft or significant loss report?

   Maintain a copy of the submitted DEA Form 106. Retaining a copy of DEA Form 106 ensures the registrant has documentation of the reported incident for audits.

8. What record must be kept when a controlled substance is transferred between registrants (e.g., invoice)?

   A record of transfer showing drug, qty, date, and parties. Transfer records must include these details to document the chain of custody between registrants.

9. What is the recordkeeping requirement for CSOS (electronic Schedule $II$ ordering) records?

   Maintain CSOS order records electronically and retrievably. CSOS records must be stored electronically and readily retrievable to comply with DEA's digital ordering system requirements for Schedule $II$.

10. What is required for filing DEA Form 222 (paper) after it is executed for a Schedule $II$ order?

    Maintain executed Form 222 in records (separate/ret.). Executed DEA Form 222 must be filed separately or retrievably to maintain accountability for Schedule $II$ transactions.

11. What is the required inventory timing when a registrant first engages in controlled substance activity?

    Initial inventory on the date controlled substances are first handled. DEA requires an initial inventory on the first day of handling to establish a baseline for accountability.

12. Which DEA form is used to document destruction of controlled substances by a registrant (when required)?

    DEA Form 41. DEA Form 41 is used by registrants to record destructions, ensuring proper documentation and accountability.

13. Which schedule's records must be kept in a separate file from Schedule $III$–$V$ records?

    Schedule $II$ records. DEA requires Schedule $II$ records to be separated from Schedule $III$–$V$ due to the higher abuse potential and stricter controls for Schedule $II$.

14. What is the federal minimum frequency for taking a controlled substance inventory after the initial inventory?

    At least every 2 years (biennial inventory). Federal law mandates biennial inventories to monitor stock and detect discrepancies in controlled substances.

15. Which controlled substance records must be maintained separately from all other pharmacy records?

    All required controlled substance records. DEA mandates that all controlled substance records be kept separate from ordinary business records to facilitate inspections and prevent commingling.

16. What record must a pharmacy maintain for each controlled substance prescription that is dispensed?

    A dispensing record for each controlled substance prescription. Pharmacies must maintain dispensing records to track controlled substance distribution and comply with federal regulations.

17. What must be documented for each controlled substance during an inventory count?

    Drug name, strength, form, and quantity on hand. Inventory must include these details to provide a complete and accurate record of controlled substances on hand.

18. Which core elements must a controlled substance dispensing record include (federal baseline)?

    Date, drug, qty, patient, prescriber, and dispenser identification. These elements are required by DEA to ensure traceability and prevent diversion in dispensing records.

19. Identify the correct filing rule: Where must Schedule $II$ dispensing records be kept relative to other records?

    In a separate Schedule $II$ file or readily retrievable from others. Schedule $II$ records must be separate or retrievable due to heightened controls on these substances.

20. Which two alternatives satisfy DEA's requirement for separating controlled substance records?

    Separate file or readily retrievable from other records. DEA allows controlled substance records to be either physically separated or readily retrievable to ensure quick access during compliance checks.

21. Which schedules may be maintained together in one controlled substance record file (federal rule)?

    Schedule $III$–$V$ records may be kept together. Federal rules permit combining Schedule $III$–$V$ records together because they share similar control levels, unlike Schedule $II$.

22. Which schedules require an exact count at inventory for all containers, not an estimated count?

    Schedule $II$ (exact count required). Schedule $II$ substances require exact counts due to their high potential for abuse and diversion.

23. What is the federal minimum retention period for required controlled substance records?

    At least 2 years. Federal DEA regulations require controlled substance records to be retained for at least 2 years to ensure traceability and support audits.

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