MPJE Compounding and Patient Counseling 2 — Questions and Answers
Question 1: Under USP <797>, which Beyond-Use Date (BUD) applies to a Category 1 sterile preparation compounded without sterility testing?
- 12 hours at room temperature or 24 hours refrigerated (Correct answer)
- 24 hours at room temperature or 72 hours refrigerated
- 48 hours at room temperature or 14 days refrigerated
- 30 days regardless of storage condition
Correct 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.
Question 2: A pharmacist receives a prescription for a compounded preparation that is commercially available. Under FDCA Section 503A, this is permissible only if:
- The prescriber provides a medical necessity statement
- The compound differs from the commercial product in a clinically significant way
- The patient has documented an allergy to the commercial product's excipient
- All of the above may be acceptable justifications (Correct answer)
Correct 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.
Question 3: Which of the following is NOT a required element of patient counseling under OBRA '90 for new prescriptions?
- Name and description of the medication
- Common severe side effects and interactions
- Proper storage of the medication
- The price comparison with generic alternatives (Correct answer)
Correct 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.
Question 4: A 503B outsourcing facility differs from a 503A compounding pharmacy primarily in that a 503B facility:
- Must compound only for individual patient prescriptions
- Can compound large batches without patient-specific prescriptions (Correct answer)
- Is exempt from CGMP requirements
- Cannot compound sterile preparations
Correct 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.
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:
- 14 days refrigerated (Correct answer)
- 35 days at controlled room temperature
- 6 months
- 30 days at any temperature
Correct answer: 14 days refrigerated
USP <795> assigns a default BUD of 14 days refrigerated for non-preserved aqueous oral non-sterile preparations.
Question 6: When counseling a patient on a compounded hormone replacement preparation, which action is most appropriate if the patient asks about the safety evidence?
- Assure the patient it is FDA-approved and rigorously tested
- Explain that compounded preparations are not FDA-approved and may lack safety/efficacy data (Correct answer)
- Advise the patient to ignore FDA concerns because the prescriber knows best
- Tell the patient that compounded preparations are equivalent to manufactured drugs
Correct 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.
Question 7: Which ISO classification is required for the Primary Engineering Control (PEC) used when preparing high-risk or Category 2 sterile compounded preparations?
- ISO Class 5 (Correct answer)
- ISO Class 7
- ISO Class 8
- ISO Class 3
Correct answer: ISO Class 5
All sterile compounding must occur within an ISO Class 5 PEC (e.g., laminar airflow workbench or biological safety cabinet).
MPJE Compounding and Patient Counseling 2
Under USP , which Beyond-Use Date (BUD) applies to a Category 1 sterile preparation compounded without sterility testing?