MPJE Compounding and Patient Counseling 3

Question 1

A pharmacist is compounding a preparation using a substance on the FDA 503A Difficult-to-Compound or Demonstrably Difficult list. This means:

Accepted Answer

The substance is prohibited from compounding under 503A

Answer

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:

Accepted Answer

Patients or their agents for new and refill prescriptions covered by Medicaid

Answer

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:

Accepted Answer

2 years

Answer

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?

Accepted Answer

Compounding must be performed pursuant to a valid prescription for an identified individual patient

Answer

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?

Accepted Answer

Proper garbing in the designated order from least-clean to most-clean areas

Answer

USP <797> requires personnel to don garb in a specific sequence progressing from the cleanest outer area inward, minimizing contamination.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE Compounding and Patient Counseling 3