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MD MPJE: Controlled Substances: CSA Scheduling, Maryland CDS Law, PDMP, and CSOS

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

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Controlled Substances: CSA Scheduling, Maryland CDS Law, PDMP, and CSOS

Two statutes, one schedule

The federal Controlled Substances Act (21 U.S.C. 801 et seq.; 21 CFR Parts 1300-1321) sets the five schedules and baseline handling rules. Maryland's Uniform Controlled Dangerous Substances Act (Health-General Article, Title 5, Subtitle 4) adopts essentially the same schedules and adds state registration and PDMP duties. Where Maryland is stricter, follow Maryland.

Federal handling essentials

  • Schedule II: no refills; a new prescription is required each time; an emergency oral order needs a written or electronic follow-up within seven days.
  • Schedules III-V: up to five refills within six months of the issue date.
  • Ordering Schedule II: DEA Form 222 or an approved electronic CSOS order signed by a person holding a valid power of attorney.
  • Inventory: a biennial inventory on a date the registrant chooses; invoices and dispensing records kept and readily retrievable.
  • Loss: significant theft or loss reported to DEA on Form 106 and to the state.

Maryland layer

  • Dispensers report each controlled substance dispensing to the Maryland PDMP, run by the Department of Health and accessed through CRISP; confirm the reporting window and required data fields in COMAR.
  • Maryland's electronic prescribing mandate for controlled substances took effect January 1, 2022, with defined exceptions such as system failure, temporary technological limitation, and shortage.
  • Pharmacists share corresponding responsibility for red flags: early refills, multiple prescribers, cash payment for high-risk opioids, distant prescribers.

Worked example

A patient presents 90 tablets of oxycodone 10 mg written 45 days earlier. Schedule II cannot be refilled, and fill-window rules limit how stale a CII may be; the pharmacist should verify the fill window, query the PDMP, and contact the prescriber rather than assume validity.

Traps

Treating CSOS as optional when a valid electronic order exists; missing PDMP reporting deadlines; confusing the six-month CIII-V refill window with Schedule II rules.