Practice Test Geeks(CNPR) Certified National Pharmaceutical Representative Practice Test
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Regulatory Compliance & Ethical Standards Flashcards

7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Regulatory Compliance & Ethical Standards flashcards as text

  1. Under the Prescription Drug Marketing Act (PDMA), which activity is strictly prohibited for pharmaceutical sales representatives?

    Answer: Reselling or trading prescription drug samples

    PDMA prohibits the sale, purchase, or trading of prescription drug samples, as samples must be distributed only to licensed practitioners for patient use.

  2. The PhRMA Code on Interactions with Healthcare Professionals limits the value of educational items a representative may provide to a healthcare professional to:

    Answer: $25 or less

    The PhRMA Code restricts educational items or practice-related items to those worth $25 or less and that are directly beneficial to patient care.

  3. A pharmaceutical rep is asked by a physician about using a drug at a dose higher than what is listed in the FDA-approved labeling. The rep should:

    Answer: Decline to discuss and refer the physician to medical affairs for an unsolicited inquiry

    Off-label promotion is prohibited; reps should direct unsolicited off-label questions to the medical affairs team who can respond appropriately.

  4. Which federal law requires pharmaceutical manufacturers to track and record all sample distributions made by their sales representatives?

    Answer: Prescription Drug Marketing Act (PDMA)

    PDMA requires manufacturers to maintain detailed records of all sample distributions, including recipient signatures and quantities, to prevent diversion.

  5. When a pharmaceutical sales rep receives a report of a serious adverse event from a healthcare provider during a sales call, the rep's first obligation is to:

    Answer: Document and report the event to the company's pharmacovigilance department promptly

    FDA regulations require manufacturers to collect and submit serious adverse event reports; reps are the frontline reporters and must escalate immediately.

  6. The Sunshine Act (Open Payments Program) requires pharmaceutical manufacturers to publicly report payments to physicians above what threshold?

    Answer: $10 per transaction or $100 aggregate annually

    Under the Sunshine Act, transfers of value exceeding $10 per transaction or $100 aggregate per year per covered recipient must be reported to CMS.

  7. A sales representative who knowingly promotes a drug for an unapproved indication may expose their company to liability under which legal framework?

    Answer: False Claims Act and the Food, Drug, and Cosmetic Act

    Off-label promotion can trigger FCA liability if it leads to false Medicare/Medicaid claims, and violates the FDCA's misbranding provisions.