MPJE Prescription Dispensing Requirements 2 — Questions and Answers
Question 1: A pharmacist receives a faxed prescription for a Schedule III controlled substance. Under federal law, which statement is correct?
- Faxed Schedule III prescriptions are permitted and may serve as the original (Correct answer)
- Faxed Schedule III prescriptions are never permitted under any circumstances
- Faxed Schedule III prescriptions require a follow-up oral confirmation within 72 hours
- Faxed Schedule III prescriptions are only permitted in long-term care facilities
Correct answer: Faxed Schedule III prescriptions are permitted and may serve as the original
Federal law (21 CFR 1306.21) permits Schedule III–V prescriptions to be transmitted by fax, and the fax may serve as the original prescription.
Question 2: Which of the following information is NOT required on a prescription label for a non-controlled legend drug under federal law?
- Name and address of the dispensing pharmacy
- Prescriber's DEA registration number (Correct answer)
- Name of the patient
- Directions for use
Correct answer: Prescriber's DEA registration number
A prescriber's DEA number is not required on a non-controlled drug prescription label; it is only relevant for controlled substance prescriptions.
Question 3: A patient requests an early refill of a Schedule III controlled substance because they will be traveling. The pharmacist may:
- Dispense up to a 30-day emergency supply at their discretion
- Dispense an early refill if the prescriber authorizes it and state law permits (Correct answer)
- Automatically refill up to 5 days early under federal law
- Deny all early refills without exception for Schedule III drugs
Correct answer: Dispense an early refill if the prescriber authorizes it and state law permits
Early refills of Schedule III–V may be dispensed if the prescriber authorizes it and state law does not prohibit the practice.
Question 4: Under the Combat Methamphetamine Epidemic Act (CMEA), the daily sales limit for ephedrine-containing OTC products is:
- 3.6 grams per purchaser per day (Correct answer)
- 7.5 grams per purchaser per day
- 9 grams per purchaser per 30 days
- 6 grams per purchaser per month
Correct answer: 3.6 grams per purchaser per day
CMEA limits daily sales to 3.6 grams of ephedrine base per purchaser per day, with a 30-day limit of 9 grams.
Question 5: Which of the following is an acceptable method for a prescriber to communicate a new Schedule II prescription to a pharmacy?
- Oral telephone order with written prescription to follow within 7 days
- Written prescription signed by the prescriber (Correct answer)
- Unsigned fax transmitted by office staff
- Text message from the prescriber's personal cell phone
Correct answer: Written prescription signed by the prescriber
Schedule II prescriptions must be written and signed by the prescriber; oral orders are only permitted in true emergencies with a written follow-up.
Question 6: A pharmacist is dispensing a 90-day supply of a maintenance medication. The patient's insurance only covers 30 days. Which statement is correct regarding the prescription label?
- Two separate labels must be generated, one for the insured and one for the patient-pay portion
- The label must reflect the total quantity dispensed regardless of billing arrangement (Correct answer)
- The label quantity must match the quantity billed to insurance
- A 90-day supply cannot be dispensed when insurance covers only 30 days
Correct answer: The label must reflect the total quantity dispensed regardless of billing arrangement
The prescription label must accurately reflect the total quantity actually dispensed to the patient, regardless of how billing is split.
Question 7: Under federal law, how long must a pharmacy retain dispensing records for Schedule II controlled substances?
- 2 years from the date of dispensing (Correct answer)
- 5 years from the date of dispensing
- 3 years from the date of dispensing
- 7 years from the date of dispensing
Correct answer: 2 years from the date of dispensing
Federal DEA regulations (21 CFR 1304.04) require that Schedule II controlled substance records be maintained for a minimum of 2 years.
A pharmacist receives a faxed prescription for a Schedule III controlled substance.
Under federal law, which statement is correct?