MPJE Dispensing and Labeling 5 — Questions and Answers
Question 1: A prescription for Adderall (amphetamine salts) specifies 'brand medically necessary.' What does this mean for the pharmacist?
- The pharmacist may still substitute a generic if it is cheaper.
- The pharmacist must dispense the brand product and cannot substitute a generic. (Correct answer)
- The note is advisory only and has no legal effect.
- The pharmacist must contact the DEA before dispensing.
Correct answer: The pharmacist must dispense the brand product and cannot substitute a generic.
A 'brand medically necessary' or equivalent notation by the prescriber prohibits generic substitution and requires the pharmacist to dispense the specified brand.
Question 2: Which situation would constitute an emergency oral dispensing of a Schedule II controlled substance under DEA regulations?
- The pharmacist cannot reach the prescriber for refill authorization.
- Immediate administration is necessary, no alternative is available, and the pharmacist cannot obtain a written Rx at that time. (Correct answer)
- The patient is a repeat customer with a chronic condition.
- The prescriber is from a different state.
Correct answer: Immediate administration is necessary, no alternative is available, and the pharmacist cannot obtain a written Rx at that time.
DEA emergency oral dispensing of Schedule II requires immediate administration necessity, no reasonable alternative, and inability to obtain a written prescription at that time.
Question 3: Under federal law, a pharmacist may dispense a controlled substance only if the prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. This principle comes from which regulation?
- 21 CFR 1306.04 (Correct answer)
- 21 CFR 1301.11
- 21 CFR 1308.11
- 21 CFR 1316.08
Correct answer: 21 CFR 1306.04
21 CFR 1306.04 establishes the legitimate medical purpose standard and places corresponding responsibility on the pharmacist.
Question 4: A label on a compounded sterile preparation (CSP) must include which of the following beyond-use date (BUD) elements?
- Date of compounding only
- Date and time of compounding or the BUD, whichever applies (Correct answer)
- Only the expiration date from the bulk drug used
- A BUD is not required for CSPs dispensed same-day
Correct answer: Date and time of compounding or the BUD, whichever applies
USP <797> requires the BUD (date and time) to appear on the label of every compounded sterile preparation.
Question 5: What is the DEA requirement for a pharmacist who partially fills a Schedule II prescription because the full quantity is not available?
- The remainder may never be dispensed; the patient must get a new prescription.
- The remaining portion must be supplied within 72 hours or a new prescription is required. (Correct answer)
- The remaining portion may be supplied anytime within 30 days.
- The partial fill requires DEA Form 41 to document the shortage.
Correct answer: The remaining portion must be supplied within 72 hours or a new prescription is required.
For Schedule II partial fills due to stock shortage, the pharmacist must supply the remainder within 72 hours or the prescriber must issue a new prescription.
Question 6: Under the Medication Guides rule (21 CFR 208), when must a pharmacist distribute an FDA-required Medication Guide?
- Only on the first fill of a new prescription
- Each time the drug is dispensed to the patient (Correct answer)
- Only when the patient requests written information
- Only when a prescriber specifically orders it
Correct answer: Each time the drug is dispensed to the patient
FDA requires Medication Guides to be dispensed with each prescription fill for drugs with a Medication Guide requirement, not just the first dispensing.
Question 7: A pharmacy technician asks a pharmacist whether they can independently counsel a patient on a new prescription. What is the correct response?
- Yes, if the technician has completed a counseling training program.
- No; patient counseling on prescription drugs must be performed by a licensed pharmacist. (Correct answer)
- Yes, if the pharmacist is present in the pharmacy.
- Yes, as long as the technician reads from the package insert.
Correct answer: No; patient counseling on prescription drugs must be performed by a licensed pharmacist.
Patient counseling on prescription medications is within the scope of pharmacist practice and cannot be delegated to pharmacy technicians under OBRA '90 and most state laws.
MPJE Dispensing and Labeling 5
A prescription for Adderall (amphetamine salts) specifies 'brand medically necessary.' What does this mean for the pharmacist?