Dispensing and Labeling Flashcards
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A pharmacist dispenses a brand-name drug when the prescription authorized generic substitution and a less expensive generic was available. Which best describes this situation?
Answer: Potential violation of state substitution laws and patient cost interests.
Most state substitution laws require or allow generic substitution when permitted, and dispensing a costlier brand without basis may violate state law and patient rights.
Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit per purchaser for ephedrine-containing OTC products?
Answer: 3.6 grams
CMEA limits retail sales of ephedrine, pseudoephedrine, and phenylpropanolamine to 3.6 grams per day per purchaser.
A pharmacist receives a faxed prescription for a Schedule II controlled substance. Under what circumstance may the pharmacist dispense based on the fax alone?
Answer: When the patient is in a long-term care facility (LTCF).
DEA regulations allow a faxed Schedule II prescription to serve as the original when dispensed to a LTCF patient, a hospice patient, or for compounded IV products.
What labeling is required on a repackaged drug distributed by a hospital pharmacy to a patient for home use?
Answer: The label must comply with state outpatient prescription labeling requirements.
When a hospital pharmacy dispenses to a patient for outpatient/home use, the container must bear all required prescription label elements under state law.
Which auxiliary label is most appropriate to affix to a prescription for tetracycline?
Answer: Avoid prolonged exposure to sunlight.
Tetracyclines cause photosensitivity, making a sun-exposure warning the most clinically relevant auxiliary label.
A pharmacist is dispensing methadone for opioid use disorder treatment. Which entity must be licensed to dispense methadone for this specific indication?
Answer: Only a DEA-registered Opioid Treatment Program (OTP).
Methadone for opioid addiction treatment must be dispensed through a federally certified Opioid Treatment Program registered with the DEA under a special registration.
What is the beyond-use date (BUD) for a non-sterile compounded preparation containing water when no stability data are available?
Answer: 14 days refrigerated
USP specifies a default BUD of 14 days when refrigerated for non-sterile aqueous preparations lacking stability data.