MPJE Compounding and Patient Counseling 5 — Questions and Answers
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:
- Listed on an FDA-approved bulk drug substances list or subject to a clinical need exemption (Correct answer)
- Obtained from a licensed supplier in any foreign country
- Used only in oral dosage forms
- Accompanied by a Certificate of Analysis from any lab
Correct answer: Listed on an FDA-approved bulk drug substances list or subject to a clinical need exemption
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?
- Written information alone satisfies OBRA '90 counseling requirements
- Verbal counseling offers the interactive opportunity to address patient-specific questions (Correct answer)
- Written information is more legally protective for the pharmacy
- OBRA '90 prohibits written information as a substitute for verbal counseling
Correct answer: Verbal counseling offers the interactive opportunity to address patient-specific questions
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?
- Physical and chemical stability of the active ingredient
- Container-closure system used
- Geographic location of the pharmacy (Correct answer)
- Presence or absence of a preservative
Correct answer: Geographic location of the pharmacy
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:
- Patient refused consultation — no action taken
- Offer to counsel made; patient declined; prescription dispensed (Correct answer)
- Counseling provided regarding compounded topical pain cream
- Patient educated via written material only
Correct answer: Offer to counsel made; patient declined; prescription dispensed
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?
- The drugs are widely available commercially, so compounding provides no advantage
- Compounding these products presents risks that cannot be adequately mitigated in a pharmacy setting (Correct answer)
- They are controlled substances subject to DEA quotas
- The raw materials are too expensive to obtain through licensed suppliers
Correct answer: Compounding these products presents risks that cannot be adequately mitigated in a pharmacy setting
The 'demonstrably difficult to compound' designation reflects FDA's finding that safe preparation cannot be reliably achieved in a compounding pharmacy environment.
Question 6: A compounding pharmacist prepares a sterile ophthalmic solution. The preparation must be isotonic primarily because:
- It reduces the cost of raw materials used
- Hypertonic or hypotonic solutions cause discomfort and potential corneal damage (Correct answer)
- FDA regulations require a specific tonicity range for all sterile products
- Isotonicity extends the Beyond-Use Date of the preparation
Correct answer: Hypertonic or hypotonic solutions cause discomfort and potential corneal damage
Ophthalmic preparations must be isotonic to minimize irritation and prevent osmotic damage to ocular tissues.
Question 7: Which of the following best describes the pharmacist's responsibility under the MPJE regarding patient counseling documentation in most states?
- Documentation is optional because counseling is a professional courtesy, not a legal mandate
- Pharmacists must document only when the patient refuses counseling
- Pharmacists should maintain a record of the counseling offer and outcome for each dispensed prescription (Correct answer)
- Documentation is only required for Schedule II controlled substances
Correct answer: Pharmacists should maintain a record of the counseling offer and outcome for each dispensed prescription
Most state practice acts require pharmacists to maintain documentation of the counseling offer and its outcome for all dispensed prescriptions.
MPJE Compounding and Patient Counseling 5
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: