Controlled Substances: Scheduling, Registration, Ordering, Recordkeeping, and Prescriptions
The CSA framework
Schedules I through V rest on three findings: abuse potential, accepted medical use, and dependence liability. Schedule I has no accepted medical use. Registration is location-specific (each principal place of business), renewed every three years, with a power of attorney for agents; practitioners also need state authority to prescribe. Since the MATE Act, practitioners must attest to training on substance use disorder at registration and renewal.
Ordering and records
Schedule II is ordered on DEA Form 222 (single-sheet, or CSOS electronically) and cannot be ordered on an invoice; Schedules III-V move on invoices. Take an initial inventory when first registered and a biennial inventory thereafter, exact counts for Schedule II and estimated counts for III-V. Keep records two years and keep Schedule II records separate or readily retrievable. Report theft or significant loss on DEA Form 106 within one business day of discovery; destroy on Form 41, typically through a reverse distributor.
Prescriptions
Schedule II: no refills; an emergency oral order must be followed by a written or electronic prescription within seven days. Partial fills: the balance within 72 hours, or up to 60 days for long-term care residents and terminally ill patients. Schedules III-V: up to five refills within six months of issue. The CMEA limits pseudoephedrine to 3.6 g per day and 9 g per 30 days, with logbook, identification, and two-year retention.
Traps
A pharmacist has independent "corresponding responsibility" for red flags even on a facially valid prescription. An expired-looking Schedule II prescription is a state question, not a federal one. Federal rules now allow a one-time transfer of an unfilled electronic Schedule II prescription between retail pharmacies for initial filling, but state law may not.
Rule of thumb
Remember 2-2-2: two years of records, biennial inventory, Form 222 for Schedule II only.