Dispensing and Labeling Flashcards
7 cards from real MPJE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Dispensing and Labeling flashcards as text
A prescription for Adderall (amphetamine salts) specifies 'brand medically necessary.' What does this mean for the pharmacist?
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.
Which situation would constitute an emergency oral dispensing of a Schedule II controlled substance under DEA regulations?
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.
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?
Answer: 21 CFR 1306.04
21 CFR 1306.04 establishes the legitimate medical purpose standard and places corresponding responsibility on the pharmacist.
A label on a compounded sterile preparation (CSP) must include which of the following beyond-use date (BUD) elements?
Answer: Date and time of compounding or the BUD, whichever applies
USP requires the BUD (date and time) to appear on the label of every compounded sterile preparation.
What is the DEA requirement for a pharmacist who partially fills a Schedule II prescription because the full quantity is not available?
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.
Under the Medication Guides rule (21 CFR 208), when must a pharmacist distribute an FDA-required Medication Guide?
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.
A pharmacy technician asks a pharmacist whether they can independently counsel a patient on a new prescription. What is the correct response?
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.