MPJE Compounding and Patient Counseling 4 — Questions and Answers
Question 1: A pharmacist compounds a topical preparation using ingredients obtained from a DEA-registered source but fails to keep a log. Which regulation is primarily violated?
- USP <795> compounding records requirement
- FDCA adulteration provisions
- DEA record-keeping requirements for controlled substance precursors (Correct answer)
- OBRA '90 patient counseling standards
Correct answer: DEA record-keeping requirements for controlled substance precursors
DEA regulations require pharmacies to maintain accurate records of controlled substances and their precursors; failure is a DEA record-keeping violation.
Question 2: Which scenario best illustrates appropriate 'anticipatory compounding' permitted under 503A?
- Compounding 500 units of a sterile preparation to sell to a hospital system
- Preparing a small quantity of a compound historically prescribed by local providers based on documented past prescriptions (Correct answer)
- Compounding without a prescription but with a prescriber's verbal assurance of future orders
- Stockpiling compounded products because a raw material may become scarce
Correct answer: Preparing a small quantity of a compound historically prescribed by local providers based on documented past prescriptions
503A permits limited anticipatory compounding based on a history of receiving valid prescriptions for a preparation in the ordinary course of practice.
Question 3: A patient counseling session should include information about what to do if a dose is missed. Under MPJE standards, this counseling element falls under:
- Instructions for use of the medication (Correct answer)
- Storage and disposal information
- Common adverse effects
- Drug-disease interactions
Correct answer: Instructions for use of the medication
Instructions for use, including missed-dose procedures, are a core counseling element under OBRA '90 and state pharmacy practice standards.
Question 4: USP <797> requires that a Media Fill Test for high-risk CSP qualification be performed:
- Every 6 months (Correct answer)
- Annually
- Every 3 months
- Only upon initial competency establishment
Correct answer: Every 6 months
Personnel preparing high-risk (Category 2) CSPs must pass a media fill test at least every 6 months to maintain sterile technique qualification.
Question 5: Which statement about compounding for office use under 503A is accurate?
- 503A pharmacies may furnish reasonable quantities of compounded preparations to practitioners for office administration if permitted by state law (Correct answer)
- 503A pharmacies may not provide any compounded preparations to practitioners without a patient-specific prescription
- Office-use compounding is unlimited under 503A as long as the drug is not on a federal prohibited list
- Office-use supply from 503A pharmacies is only permitted for controlled substances
Correct answer: 503A pharmacies may furnish reasonable quantities of compounded preparations to practitioners for office administration if permitted by state law
503A permits limited office-use supply to practitioners in reasonable quantities when authorized by the state board of pharmacy.
Question 6: When a pharmacist detects during counseling that a patient is taking a newly prescribed drug that interacts with a current medication, the pharmacist's primary obligation is to:
- Dispense and document without notifying anyone since the prescriber is responsible
- Refuse to dispense until the patient sees the prescriber again
- Notify the prescriber and counsel the patient about the interaction before dispensing (Correct answer)
- Call poison control and file a medication error report
Correct answer: Notify the prescriber and counsel the patient about the interaction before dispensing
The pharmacist's professional duty is to identify the interaction, notify the prescriber, and counsel the patient prior to or instead of dispensing.
Question 7: A 503B outsourcing facility must register with:
- State Board of Pharmacy only
- FDA only
- Both the FDA and the state Board of Pharmacy (Correct answer)
- DEA and FDA jointly
Correct answer: Both the FDA and the state Board of Pharmacy
503B facilities must register with the FDA and are also subject to state pharmacy board licensing and oversight.
MPJE Compounding and Patient Counseling 4
A pharmacist compounds a topical preparation using ingredients obtained from a DEA-registered source but fails to keep a log.
Which regulation is primarily violated?