Controlled Substances: Federal and State Requirements
Controlled Substances: Federal and State Requirements
This domain tests the CSA, DEA registration and recordkeeping, prescription rules for Schedules II–V, and ND's controlled-substance law in NDCC Chapter 19-03.1 and Board rules. Expect questions on schedule classification, refills, partial fills, transfers, the PDMP, and security.
Core rules
- Schedules: I has no accepted medical use; II–V have accepted medical use with decreasing abuse potential. ND schedules generally mirror federal schedules, but ND may add or restrict substances.
- Registration: practitioners and pharmacies need DEA registration; C-II purchases use DEA Form 222 or CSOS; records must be readily retrievable and kept at least two years federally, while ND requires longer pharmacy record retention.
- C-II: no refills. A prescription may be written, electronic, or oral only in an emergency with written follow-up within 7 days. Partial fills: if the pharmacist cannot supply the full quantity, the remainder may be filled within 72 hours; if the patient or prescriber requests a partial fill, the remainder may be filled within 30 days of the date written.
- C-III–V: maximum 5 refills within 6 months from the date written.
- PDMP: ND requires dispensers to report controlled-substance dispensing; use the PDMP to identify multiple prescribers/pharmacies and early refills.
- Security/theft: report significant loss or theft to DEA and the ND Board; keep C-II under lock or other effective controls.
Worked example
A patient presents a C-II for 60 tablets on March 1. The pharmacy has only 30. The pharmacist may partially fill 30 and must supply the remaining 30 within 72 hours; if not, notify the prescriber and do not dispense the remainder. If the patient instead asks for only 30 now, the remainder may be filled within 30 days of March 1. The reasoning turns on who requested the partial fill.
Traps
- Refilling a C-II or applying the 6-month rule to C-II.
- Using the same deadline for all partial fills.
- Ignoring a stricter ND rule on transfers or prescription validity.
- Failing to report theft or significant loss.