Controlled Substances and Other Regulated Drugs
Scheduling and registration
Controlled substances are placed in Schedules II–V under the federal CSA and NC law. Prescribers, dispensers, and distributors need DEA registration; the pharmacy also needs the appropriate state authority. Schedule II has no refills. Schedules III–V may be refilled up to five times within six months from the date of issue, unless the prescriber limits refills. A Schedule II oral emergency order may be dispensed only if the pharmacist receives a written prescription within seven days.
NC reporting and monitoring
North Carolina dispensers report controlled-substance dispensing to the Controlled Substances Reporting System (CSRS). Prescribers and pharmacists have query obligations for specified drugs and must document efforts. Electronic prescribing of controlled substances is required in NC with limited exceptions. The pharmacy must keep controlled-substance records, including a biennial inventory, and secure stock against theft.
Worked example
A prescriber phones in a Schedule II opioid for a patient after hours because the office is closing. The pharmacist may dispense on the oral order if the requirements are met, but must obtain a written prescription within seven days. The pharmacist documents the oral order, the emergency, and the follow-up. If the written prescription never arrives, the pharmacist must not treat the oral order as an indefinite authorization.
Traps
Refilling Schedule II; exceeding five refills or six months for III–V; failing to report to CSRS; missing the seven-day written follow-up; and accepting an invalid or expired prescription.