Compounding and Patient Counseling 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 Compounding and Patient Counseling flashcards as text
A pharmacist is compounding a preparation using a substance on the FDA 503A Difficult-to-Compound or Demonstrably Difficult list. This means:
Answer: The substance is prohibited from compounding under 503A
Substances on the FDA's 503A 'difficult to compound' or 'demonstrably difficult' categories are prohibited from being compounded under 503A.
Under OBRA '90, a pharmacist's offer to counsel must be made to:
Answer: Patients or their agents for new and refill prescriptions covered by Medicaid
OBRA '90 specifically requires the offer to counsel for Medicaid patients, though many states have extended this requirement to all patients.
A compounding record for a non-sterile preparation must be maintained for at least:
Answer: 2 years
USP and most state boards require compounding records for non-sterile preparations to be retained for a minimum of 2 years.
Which statement best describes the 'patient-specific' requirement under FDCA Section 503A?
Answer: Compounding must be performed pursuant to a valid prescription for an identified individual patient
503A requires compounding to occur pursuant to a valid prescription for a specifically identified individual patient, not in anticipation of future orders.
Which personnel action is required before a pharmacist or pharmacy technician enters an ISO Class 7 or 8 buffer room for sterile compounding?
Answer: Proper garbing in the designated order from least-clean to most-clean areas
USP requires personnel to don garb in a specific sequence progressing from the cleanest outer area inward, minimizing contamination.
When a patient declines counseling, the pharmacist should:
Answer: Document the declination and dispense the prescription
If a patient declines the offer to counsel, the pharmacist should document the refusal and proceed with dispensing the prescription.
Under USP , which type of hazardous drug preparation requires the use of a Containment Primary Engineering Control (C-PEC)?
Answer: Any compounding of NIOSH Group 1 antineoplastic drugs
USP mandates a C-PEC for compounding NIOSH Group 1 antineoplastic agents and other hazardous drugs requiring containment controls.