PTCB Certified Pharmacy Technician (PTCE)Federal RequirementsMedium

A pharmacy technician receives a prescription for fentanyl transdermal patches. The prescriber has indicated 'PRN pain' on the prescription. What federal requirement makes this prescription problematic for dispensing?

  1. AFederal law requires a specific diagnosis to be written on all Schedule II prescriptions.
  2. BThe DEA requires a specific dosage regimen for all Schedule II controlled substances, including frequency and duration.
  3. CFentanyl is a Schedule II drug and cannot be prescribed for 'PRN' use.
  4. DThe quantity of fentanyl patches must be explicitly stated, not implied by 'PRN'.
Show answer & explanation

Correct answer: B. The DEA requires a specific dosage regimen for all Schedule II controlled substances, including frequency and duration.

Federal regulations, specifically related to Schedule II controlled substances, mandate that prescriptions include a specific dosage regimen, which means a defined frequency and duration, not just 'PRN' (as needed) without further clarification.

Why the other options are wrong

  • A. Federal law does not universally require a diagnosis on all C-II prescriptions, although it's good practice and often required by state law.
  • C. While fentanyl is C-II, 'PRN' use is not inherently prohibited if a clear regimen is provided (e.g., 'apply 1 patch every 72 hours PRN pain'). The issue is the lack of a specific regimen.
  • D. The quantity must always be stated on a C-II prescription, but 'PRN pain' primarily refers to the *frequency/duration* of administration, which is the missing element here.

Schedule II Prescription Requirements

Federal law dictates strict requirements for Schedule II prescriptions to prevent diversion and abuse.

  • Must be written (or e-prescribed) and signed by the prescriber.
  • No refills allowed.
  • Must include patient's full name and address, prescriber's full name, address, and DEA registration number.
  • Must specify drug name, strength, dosage form, quantity, and directions for use (including a specific dosage regimen).

Memory trick: C-II scripts need ALL details: Patient, Prescriber, Drug, Dose, and Regimen.

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