MPJE Prescription Dispensing Requirements Questions and Answers — Questions and Answers
Question 1: A retail pharmacy utilizes a central fill pharmacy, which is under common ownership, to prepare a prescription for zolpidem. According to federal law, which of the following statements regarding the prescription label is correct?
- The label must identify the retail pharmacy and include a unique identifier for the central fill pharmacy. (Correct answer)
- The label must identify only the central fill pharmacy and its address.
- The label is not required to identify the central fill pharmacy if it has the same owner as the retail pharmacy.
- The label must identify only the retail pharmacy and its address.
Correct answer: The label must identify the retail pharmacy and include a unique identifier for the central fill pharmacy.
According to 21 CFR 1306.24(b), when a prescription for a controlled substance is filled at a central fill pharmacy, the label must show the retail pharmacy's name and address and a unique identifier (like the DEA number) indicating that the prescription was filled at the central fill pharmacy.
Question 2: A prescriber phones in an emergency prescription for a 3-day supply of morphine sulfate for a patient in severe pain. The pharmacist immediately reduces the oral prescription to writing. What is the maximum time frame, under federal law, within which the prescriber must provide a written, signed prescription to the pharmacy?
- 14 days
- 3 days
- 7 days (Correct answer)
- 30 days
Correct answer: 7 days
Federal law under 21 CFR 1306.11(d)(4) requires that a practitioner who issues an emergency oral prescription for a Schedule II controlled substance must deliver a written, signed prescription to the dispensing pharmacist within 7 days after authorizing the emergency prescription.
Question 3: According to federal law, which of the following is a required element on the prescription label for a dispensed Schedule IV controlled substance?
- The patient's date of birth.
- A 'Caution: Federal law prohibits the transfer...' statement. (Correct answer)
- The lot number and expiration date of the drug.
- The pharmacy's DEA number.
Correct answer: A 'Caution: Federal law prohibits the transfer...' statement.
Federal law, specifically 21 CFR 290.5, requires that the label of any dispensed Schedule II, III, or IV controlled substance must contain the statement: 'CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.'
Question 4: A patient presents a valid, original paper prescription for a Schedule III controlled substance with two authorized refills. After the initial fill, the patient requests to transfer the remaining refills to a different pharmacy across town that is not part of the same chain. Assuming the pharmacies do not share a real-time, online database, how many times can this prescription be transferred?
- As many times as there are refills remaining.
- It cannot be transferred as it is a Schedule III substance.
- Twice.
- Only one time. (Correct answer)
Correct answer: Only one time.
According to 21 CFR 1306.25(a), the transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only, unless the pharmacies electronically share a real-time, online database.
Question 5: An institutional practitioner may dispense a Schedule II controlled substance for immediate administration to an ultimate user. Which of the following is a valid method for this to occur under federal law?
- Pursuant to an oral order from a registered nurse.
- Pursuant to a patient's chart order from a medical resident using their personal DEA number.
- Pursuant to an order for medication made by an individual practitioner. (Correct answer)
- Pursuant to a standing order for any patient on a specific unit.
Correct answer: Pursuant to an order for medication made by an individual practitioner.
According to 21 CFR 1306.11(c), an institutional practitioner may administer or dispense a Schedule II controlled substance directly to an ultimate user pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner that is dispensed for immediate administration.
Question 6: A patient requests to have their new, unfilled electronic prescription for zaleplon (Schedule IV) transferred from Pharmacy A to Pharmacy B for initial filling. Under the federal rule effective in 2023, which of the following conditions must be met?
- The prescription must be converted to a paper copy and faxed by the pharmacist.
- The transfer must be initiated by the prescriber's agent.
- The transfer must be communicated directly between two licensed pharmacists. (Correct answer)
- The prescription can be transferred multiple times for initial filling.
Correct answer: The transfer must be communicated directly between two licensed pharmacists.
The DEA final rule, effective August 28, 2023, allows the one-time transfer of an original, unfilled electronic prescription for a Schedule II-V controlled substance between DEA-registered pharmacies. The rule explicitly requires that the transfer must be communicated directly between two licensed pharmacists.
MPJE Prescription Dispensing Requirements Questions and Answers
A retail pharmacy utilizes a central fill pharmacy, which is under common ownership, to prepare a prescription for zolpidem.
According to federal law, which of the following statements regarding the prescription label is correct?
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