Controlled Substances - NAPLEX

1. What is the maximum number of refills allowed for a Schedule II prescription?

   Zero refills. DEA rules prohibit refills for Schedule II to prevent diversion and abuse of high-risk controlled substances.

2. What is the defining federal criterion for a Schedule II controlled substance?

   High abuse potential; accepted medical use; severe dependence risk. Schedule II classification under federal law balances recognized therapeutic applications against substantial risks of abuse and dependency.

3. What is the only circumstance when a Schedule II prescription may be taken orally by a pharmacist?

   Emergency situation; follow-up written/electronic required. Federal exceptions for Schedule II oral orders are limited to emergencies to maintain stringent controls while allowing urgent care.

4. What is the defining federal criterion for a Schedule I controlled substance?

   High abuse potential; no accepted medical use; lack of safety. The Controlled Substances Act classifies drugs into Schedule I based on criteria emphasizing maximum restrictions due to absence of medical utility and elevated risks.

5. Identify the DEA form used to report theft or significant loss of controlled substances.

   DEA Form 106. DEA Form 106 facilitates mandatory reporting of losses to enable investigations and maintain supply chain integrity.

6. What is the federal rule for transferring a controlled substance prescription between pharmacies?

   Schedules III–V: once; Schedule II: no transfers. Transfer rules differentiate schedules to enforce tighter controls on higher-risk substances while allowing flexibility for lower ones.

7. What is the defining federal criterion for a Schedule III controlled substance?

   Moderate-low abuse potential; accepted use; moderate dependence risk. Federal criteria for Schedule III reflect a moderated risk profile compared to higher schedules while acknowledging medical benefits.

8. Identify the DEA form used to register a pharmacy or practitioner to handle controlled substances.

   DEA Form 224. DEA Form 224 is required for initial registration, ensuring entities meet federal standards for handling controlled substances.

9. Which schedule(s) may be dispensed from an oral prescription under federal law in routine practice?

   Schedules III, IV, and V. Lower schedules permit oral prescriptions to facilitate access for substances with reduced abuse and dependence risks.

10. What is the required frequency for conducting a controlled substance inventory under federal law?

    At least every 2 years (biennial inventory). Biennial inventories are mandated by federal law to maintain accurate tracking and detect discrepancies in controlled stock.

11. What is the federal limit for dispensing multiple Schedule II prescriptions on the same date for sequential fills?

    May issue multiple; total up to a $90$-day supply if allowed. DEA permits multiple Schedule II prescriptions for chronic needs, capping total supply to minimize abuse potential.

12. What is the defining federal criterion for a Schedule V controlled substance?

    Lowest abuse potential; accepted use; limited dependence risk. The CSA places substances in Schedule V due to their minimal abuse potential and established medical uses with low dependency risks.

13. Which schedule requires exact count in the inventory (not an estimated count) under federal law?

    Schedule II. Exact counts for Schedule II are required due to their high abuse potential, ensuring precise inventory accountability.

14. Which schedules require a written or electronic prescription (not oral) in non-emergency situations?

    Schedule II. Non-emergency Schedule II requires written or electronic format to ensure traceability and prevent unauthorized dispensing.

15. What is the maximum number of refills allowed for a Schedule V prescription under federal law?

    As authorized by the prescriber. Schedule V's lower abuse risk allows prescriber discretion in refills without strict federal numerical limits.

16. What is the minimum federal record retention period for controlled substance prescriptions and inventories?

    At least 2 years. The 2-year retention supports DEA audits and investigations into controlled substance handling and diversion.

17. Which schedules must be stored in a securely locked, substantially constructed cabinet or dispersed to deter theft?

    Schedules II–V. Secure storage requirements for these schedules aim to prevent theft and diversion under DEA physical security regulations.

18. What is the maximum federal days' supply allowed on an emergency Schedule II oral prescription?

    Only the amount needed during the emergency period. Emergency Schedule II dispensing is restricted to minimal quantities to address immediate needs without enabling excess supply.

19. What is the defining federal criterion for a Schedule IV controlled substance?

    Low abuse potential vs Schedule III; limited dependence risk. Schedule IV drugs are designated under the CSA for their reduced abuse liability relative to Schedule III with accepted medical applications.

20. Identify the DEA form used to order Schedule II controlled substances from a supplier.

    DEA Form 222 (or CSOS electronic equivalent). DEA Form 222 provides a secure, triplicate system for ordering Schedule II to track and prevent diversion.

21. What is the federal rule on partial filling a Schedule II prescription for a patient who cannot receive the full quantity?

    Remainder must be filled within 72 hours or forfeited. The 72-hour rule for partial Schedule II fills prevents indefinite holds and reduces diversion risks.

22. What is the maximum number of refills allowed for a Schedule III or IV prescription?

    Up to 5 refills. Federal law limits refills for Schedules III and IV to balance access with controls on substances with moderate abuse potential.

23. What is the maximum time window after issuance to refill a Schedule III or IV prescription under federal law?

    Within 6 months of the date written. The 6-month refill window for Schedules III and IV ensures prescriptions remain valid only for a reasonable period under federal guidelines.

24. Which schedule has the most restrictive prescribing and ordering requirements under federal law?

    Schedule II. Federal regulations impose the strictest controls on Schedule II substances to mitigate their high abuse and dependence potential.

25. What is the federal deadline for the prescriber to provide the written follow-up after an emergency Schedule II oral order?

    Within 7 days. The 7-day requirement ensures documentation follows emergency oral Schedule II orders to comply with DEA accountability standards.

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