Compounding and Patient Counseling Flashcards
7 cards from real MPJE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Compounding and Patient Counseling flashcards as text
Under USP , which Beyond-Use Date (BUD) applies to a Category 1 sterile preparation compounded without sterility testing?
Answer: 12 hours at room temperature or 24 hours refrigerated
Category 1 CSPs lacking sterility testing have a BUD of 12 hours at controlled room temperature or 24 hours refrigerated.
A pharmacist receives a prescription for a compounded preparation that is commercially available. Under FDCA Section 503A, this is permissible only if:
Answer: All of the above may be acceptable justifications
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.
Which of the following is NOT a required element of patient counseling under OBRA '90 for new prescriptions?
Answer: The price comparison with generic alternatives
OBRA '90 mandates counseling on drug name, indication, side effects, interactions, storage, and monitoring, but does not require price comparisons.
A 503B outsourcing facility differs from a 503A compounding pharmacy primarily in that a 503B facility:
Answer: Can compound large batches without patient-specific prescriptions
503B outsourcing facilities may produce large sterile batches for healthcare facilities without patient-specific prescriptions but must comply with CGMP.
Under USP , a non-sterile compounded preparation with an aqueous oral dosage form that uses no preservatives has a default BUD of:
Answer: 14 days refrigerated
USP assigns a default BUD of 14 days refrigerated for non-preserved aqueous oral non-sterile preparations.
When counseling a patient on a compounded hormone replacement preparation, which action is most appropriate if the patient asks about the safety evidence?
Answer: Explain that compounded preparations are not FDA-approved and may lack safety/efficacy data
Pharmacists must honestly inform patients that compounded hormone preparations are not FDA-approved and supporting efficacy/safety data may be limited.
Which ISO classification is required for the Primary Engineering Control (PEC) used when preparing high-risk or Category 2 sterile compounded preparations?
Answer: ISO Class 5
All sterile compounding must occur within an ISO Class 5 PEC (e.g., laminar airflow workbench or biological safety cabinet).