MPJE Compounding and Patient Counseling 2

Question 1

Under USP <797>, which Beyond-Use Date (BUD) applies to a Category 1 sterile preparation compounded without sterility testing?

Accepted Answer

12 hours at room temperature or 24 hours refrigerated

Answer

Category 1 CSPs lacking sterility testing have a BUD of 12 hours at controlled room temperature or 24 hours refrigerated.

Question 2

A pharmacist receives a prescription for a compounded preparation that is commercially available. Under FDCA Section 503A, this is permissible only if:

Accepted Answer

All of the above may be acceptable justifications

Answer

Section 503A allows compounding a commercially available drug when there is a valid clinical reason such as allergy to an excipient, required dosage form change, or documented medical necessity.

Question 3

Which of the following is NOT a required element of patient counseling under OBRA '90 for new prescriptions?

Accepted Answer

The price comparison with generic alternatives

Answer

OBRA '90 mandates counseling on drug name, indication, side effects, interactions, storage, and monitoring, but does not require price comparisons.

Question 4

A 503B outsourcing facility differs from a 503A compounding pharmacy primarily in that a 503B facility:

Accepted Answer

Can compound large batches without patient-specific prescriptions

Answer

503B outsourcing facilities may produce large sterile batches for healthcare facilities without patient-specific prescriptions but must comply with CGMP.

Question 5

Under USP <795>, a non-sterile compounded preparation with an aqueous oral dosage form that uses no preservatives has a default BUD of:

Accepted Answer

14 days refrigerated

Answer

USP <795> assigns a default BUD of 14 days refrigerated for non-preserved aqueous oral non-sterile preparations.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE Compounding and Patient Counseling 2