Compounding and Patient Counseling Flashcards
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Read the first 7 Compounding and Patient Counseling flashcards as text
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:
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.
Which element distinguishes written counseling information (e.g., patient package inserts) from verbal counseling under OBRA '90?
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.
Under USP , which factor does NOT influence the assigned Beyond-Use Date of a non-sterile compounded preparation?
Answer: Geographic location of the pharmacy
USP BUD is determined by stability data, storage conditions, container type, and preservative status, not the pharmacy's geographic location.
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:
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.
Which of the following is a primary reason the FDA has listed certain drug products on the 503A 'Demonstrably Difficult to Compound' list?
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.
A compounding pharmacist prepares a sterile ophthalmic solution. The preparation must be isotonic primarily because:
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.
Which of the following best describes the pharmacist's responsibility under the MPJE regarding patient counseling documentation in most states?
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.