MPJE Compounding and Patient Counseling Questions and Answers

Question 1

Under the federal Omnibus Budget Reconciliation Act of 1990 (OBRA '90), which of the following statements is accurate regarding the patient counseling requirement for a new Medicaid prescription?

Accepted Answer

The offer to counsel must be made, but the patient or their caregiver has the right to refuse it.

Answer

Counseling is only required if the patient explicitly asks for it.

Answer

A pharmacy technician may provide the full counseling session if the pharmacist is unavailable.

Answer

The law mandates that written information, like a patient leaflet, is a sufficient substitute for a verbal offer to counsel.

Question 2

Which of the following is a primary distinction between a 503A compounding pharmacy and a 503B outsourcing facility under the Federal Food, Drug, and Cosmetic Act?

Accepted Answer

503A pharmacies must compound based on a valid patient-specific prescription and are not required to follow full Current Good Manufacturing Practices (cGMP).

Answer

503B facilities can compound sterile products, while 503A pharmacies are restricted to non-sterile compounding only.

Answer

503A pharmacies are prohibited from performing any anticipatory compounding.

Answer

503B facilities are licensed only by state boards of pharmacy, whereas 503A pharmacies must register with the FDA.

Question 3

When preparing a compounded batch of 'Magic Mouthwash' for the first time, a pharmacist creates a detailed 'recipe' document that includes the ingredients, quantities, mixing instructions, and quality control procedures. Which of the following best describes this document?

Accepted Answer

Master Formulation Record

Answer

Standard Operating Procedure (SOP)

Answer

Compounding Record

Answer

Safety Data Sheet (SDS)

Question 4

A pharmacist is counseling a patient on a new prescription for warfarin. According to the principles established by OBRA '90, which of the following points of information is the pharmacist expected to cover during the counseling session?

Accepted Answer

Common severe side effects or adverse effects.

Answer

The manufacturer's wholesale acquisition cost.

Answer

The pharmacy's current inventory level of the medication.

Answer

The date the drug's patent is set to expire.

Question 5

A pharmacy technician, under the supervision of a pharmacist, is preparing a non-hazardous, non-sterile topical cream. The technician is wearing a clean lab coat and gloves. According to USP <795> guidelines, which of the following is also a common requirement for personal protective equipment (PPE) to prevent contamination of the preparation?

Accepted Answer

A face mask.

Answer

A disposable chemotherapy gown.

Answer

A full-face respirator.

Answer

Sterile gloves.

Question 6

Under federal law, a traditional 503A pharmacy may compound a drug product in limited quantities before the receipt of a prescription for an individual patient. This practice is known as:

Accepted Answer

Anticipatory compounding

Answer

Outsourcing

Answer

cGMP manufacturing

Answer

Office-use compounding