Controlled Substances: Scheduling, Ordering, Records, and Reporting
Controlled-substance questions test scheduling, ordering, recordkeeping, inventory, and reporting. Federal DEA rules set minimum standards; state boards and PDMPs add requirements.
Core rules
- Schedule I drugs have no accepted medical use; Schedule II has high abuse potential and no refills; Schedules III–V may be refilled up to five times within six months unless state law is stricter.
- Pharmacies order Schedule II with DEA Form 222 or CSOS; Schedules III–V use invoices. All controlled-substance records must be kept and readily retrievable, generally two years.
- A biennial inventory is required; Schedule II counts are exact, and Schedule III–V counts may be estimated under DEA rules. Newly scheduled drugs require an initial inventory.
- Theft or significant loss requires notification to DEA and state authorities, often using DEA Form 106. PDMP queries and reporting are state-specific.
- Security, power of attorney, registration, and disposal rules apply; expired stock must be handled through a reverse distributor or authorized collection.
Worked example
A pharmacist discovers 30 oxycodone tablets missing. The pharmacist secures the area, documents the count, notifies the DEA field office and state board as required, and files DEA Form 106. The reasoning: loss reporting is not optional, and the pharmacy must reconcile records while preserving evidence. A CII prescription with refills would be invalid; the pharmacy cannot simply refill it.
Traps
Refilling a Schedule II prescription; using DEA Form 222 for CIII–V; missing the two-year record retention; and treating a loss as an inventory adjustment without reporting.