PTCE - Federal Requirements (18.75% of the exam) - Section 2.2

Apply federal requirements for controlled substance prescriptions (new, refill, and transfer) and DEA controlled substance schedules. (Calculation-based.)

Apply DEA scheduling criteria to distinguish Schedule II through V controlled substances, their respective refill limits, and the federal rules governing prescription transfers. Verify that a controlled substance prescription meets all federal validity requirements - including quantity limits and prescriber authorisation - before processing.

DEA scheduleControlled substance prescriptionRefill limitsSchedule II-V

Practice question for this objective

Free sampleFederal Requirementshard

A prescriber writes a valid prescription for a Schedule II opioid. Under federal law, how many refills may the pharmacy authorise and dispense from this written prescription?

AUp to 5 refills within 6 months of the date written
BNo refills are permitted; a new prescription is required each time Correct
CUp to 5 refills within 12 months of the date written
DOne refill is permitted if the prescriber notes it on the prescription

Schedule II controlled substance prescriptions may not be refilled; each fill requires a new prescription. The Controlled Substances Act bars refills on Schedule II drugs because of their high abuse potential, so a new written or EPCS prescription is mandatory for every supply rather than a refill on the original.

Why A is wrong: This is the federal limit for Schedule III to V drugs, and a candidate may wrongly apply that familiar rule to all controlled substances; for Schedule II no refills are permitted at all.

Why B is correct: Federal law prohibits refilling a Schedule II prescription, so each fill requires a fresh prescription; this is the defining dispensing rule for CII drugs.

Why C is wrong: Both the 5-refill allowance and the timeframe are wrong for Schedule II; the 12-month window is the general limit for non-controlled legend drugs, which tempts candidates who blur the two systems.

Why D is wrong: No prescriber annotation can authorise a Schedule II refill; this option is tempting because partial fills and prescriber notes do exist, but they never create a refill for CII.

See more PTCE practice questions, answers explained.

Exam traps in Federal Requirements

Answers that look right on this material and are not. Each one is a distractor from a different question in the PTCE bank for this domain.

Schedule I drugs have an accepted medical use but the highest abuse potential
Why it is wrong: Schedule I drugs have a high abuse potential but no currently accepted medical use, so pairing them with an accepted use is the defining error that distinguishes Schedule I from Schedule II.
The collecting customer's employer and place of work must be written on the prescription record.
Why it is wrong: Tempting because identification of who collects medicine sounds thorough, but federal controlled substance recordkeeping does not require recording the collector's employer or workplace.
New Schedule II prescriptions may be faxed and dispensed directly from the fax in all cases
Why it is wrong: A fax may serve only as written confirmation in specific situations and generally cannot be dispensed as the original CII prescription; treating every fax as dispensable is a common but incorrect assumption.

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