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DE MPJE: Delaware Controlled Substances Law

DE MPJE · Work through your exam, one topic at a time.

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Delaware Controlled Substances Law

Delaware Controlled Substances Law tests 16 Del. C. ch. 47 and Office of Controlled Substances rules: registration, scheduling, prescription limits, PMP reporting, security, and loss reporting. Delaware uses the federal schedules but requires a state controlled substance registration (CSR) in addition to DEA registration.

Registration and schedule

  • A practitioner or pharmacy that handles controlled substances needs both a Delaware CSR and a DEA registration. Schedule I has no accepted medical use; Schedules II-V mirror the federal scheme and can be modified by regulation.
  • Maintain a biennial inventory, secure storage, and records of receipt and disposition. Only authorized personnel may access controlled substances.

Prescription rules

  • Schedule II requires a written or electronic prescription and no refills. An emergency oral Schedule II order may be dispensed only if the prescriber delivers a written/electronic prescription within 7 days.
  • Schedule III-IV prescriptions may be refilled up to five times within six months of issue. Schedule V refills follow the prescription and state limits. Verify prescriber DEA/CSR, patient, drug, strength, quantity, directions, and date.
  • Delaware limits initial opioid prescriptions for acute pain to a 7-day supply, subject to statutory exceptions. Confirm the exception before dispensing beyond the limit.
  • Dispensers report controlled-substance dispensing to the Delaware PMP; prescribers have PMP query duties for specified opioids/benzodiazepines. Distinguish reporting from querying.
  • Report theft or significant loss to DEA and the Delaware Office of Controlled Substances; use DEA Form 41 for destruction and a reverse distributor for unwanted stock.

Worked example

A prescriber calls in an oral Schedule II opioid for a patient with acute pain on Friday afternoon. The pharmacist may dispense a limited emergency supply only if the prescriber agrees to send a written or electronic prescription within 7 days. The pharmacist documents the oral order, quantity, and follow-up. If the written prescription does not arrive, no further Schedule II dispensing occurs; a refill is never allowed.

Traps

The biggest trap is DEA-only registration. Do not refill a Schedule II prescription or treat “five refills” as applying to CII. Do not assume the pharmacist has the same PMP query duty as the prescriber; know whether the question asks about reporting or checking. Do not ignore the 7-day follow-up for emergency oral CII. Do not destroy controlled substances without the required form and witnesses.