MPJE Compounding and Patient Counseling 3 — Questions and Answers
Question 1: A pharmacist is compounding a preparation using a substance on the FDA 503A Difficult-to-Compound or Demonstrably Difficult list. This means:
- The substance is prohibited from compounding under 503A (Correct answer)
- The pharmacy must obtain a variance from the state board
- The substance requires enhanced documentation in the compounding record
- The pharmacist may still compound it with prescriber authorization
Correct 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.
Question 2: Under OBRA '90, a pharmacist's offer to counsel must be made to:
- Only patients picking up new prescriptions for the first time
- Patients or their agents for new and refill prescriptions covered by Medicaid (Correct answer)
- All patients picking up any prescription regardless of payer source
- Only patients at high risk for medication errors
Correct 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.
Question 3: A compounding record for a non-sterile preparation must be maintained for at least:
- 1 year
- 2 years (Correct answer)
- 3 years
- 5 years
Correct answer: 2 years
USP <795> and most state boards require compounding records for non-sterile preparations to be retained for a minimum of 2 years.
Question 4: Which statement best describes the 'patient-specific' requirement under FDCA Section 503A?
- Compounding must be performed pursuant to a valid prescription for an identified individual patient (Correct answer)
- A pharmacy may compound batches in advance for anticipated prescriptions without violating 503A
- The requirement only applies to controlled substance compounds
- Patient-specific means the pharmacist must personally know the patient
Correct 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.
Question 5: Which personnel action is required before a pharmacist or pharmacy technician enters an ISO Class 7 or 8 buffer room for sterile compounding?
- Completion of annual sterile technique competency training only
- Proper garbing in the designated order from least-clean to most-clean areas (Correct answer)
- Obtaining a physician clearance for no active skin conditions
- Wearing standard lab coat and gloves is sufficient
Correct answer: Proper garbing in the designated order from least-clean to most-clean areas
USP <797> requires personnel to don garb in a specific sequence progressing from the cleanest outer area inward, minimizing contamination.
Question 6: When a patient declines counseling, the pharmacist should:
- Refuse to dispense the prescription until counseling is accepted
- Document the declination and dispense the prescription (Correct answer)
- Report the refusal to the prescriber immediately
- Require a signed waiver before dispensing
Correct 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.
Question 7: Under USP <800>, which type of hazardous drug preparation requires the use of a Containment Primary Engineering Control (C-PEC)?
- All non-sterile compounding regardless of hazard classification
- Any compounding of NIOSH Group 1 antineoplastic drugs (Correct answer)
- Only oral solid reformulation of hazardous drugs
- Hazardous drugs only when prepared in quantities exceeding 100 units
Correct answer: Any compounding of NIOSH Group 1 antineoplastic drugs
USP <800> mandates a C-PEC for compounding NIOSH Group 1 antineoplastic agents and other hazardous drugs requiring containment controls.
MPJE Compounding and Patient Counseling 3
A pharmacist is compounding a preparation using a substance on the FDA 503A Difficult-to-Compound or Demonstrably Difficult list.
This means: