MPJE Compounding and Patient Counseling 5

Question 1

A pharmacy compounds a drug product using bulk active pharmaceutical ingredients (APIs) that are not FDA-approved. Under 503A, this is permissible only if the API is:

Accepted Answer

Listed on an FDA-approved bulk drug substances list or subject to a clinical need exemption

Answer

503A permits compounding from bulk APIs only if the substance appears on the FDA's positive list of bulk drug substances that can be used in compounding.

Question 2

Which element distinguishes written counseling information (e.g., patient package inserts) from verbal counseling under OBRA '90?

Accepted Answer

Verbal counseling offers the interactive opportunity to address patient-specific questions

Answer

Verbal counseling allows the pharmacist to tailor information and answer specific patient questions, which written materials cannot fully replace.

Question 3

Under USP <795>, which factor does NOT influence the assigned Beyond-Use Date of a non-sterile compounded preparation?

Accepted Answer

Geographic location of the pharmacy

Answer

USP <795> BUD is determined by stability data, storage conditions, container type, and preservative status, not the pharmacy's geographic location.

Question 4

A pharmacist receives a refusal to counsel from a patient picking up a compounded pain cream for the first time. The best documentation entry is:

Accepted Answer

Offer to counsel made; patient declined; prescription dispensed

Answer

Proper documentation should reflect that the offer was made, the patient declined, and the prescription was dispensed to create a legally accurate record.

Question 5

Which of the following is a primary reason the FDA has listed certain drug products on the 503A 'Demonstrably Difficult to Compound' list?

Accepted Answer

Compounding these products presents risks that cannot be adequately mitigated in a pharmacy setting

Answer

The 'demonstrably difficult to compound' designation reflects FDA's finding that safe preparation cannot be reliably achieved in a compounding pharmacy environment.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE Compounding and Patient Counseling 5