MPJE Dispensing and Labeling 3 — Questions and Answers
Question 1: 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?
- Acceptable practice if the pharmacist documents the reason.
- Potential violation of state substitution laws and patient cost interests. (Correct answer)
- Required by federal law to dispense brand when available.
- Permitted as long as the patient is notified after dispensing.
Correct 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.
Question 2: Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit per purchaser for ephedrine-containing OTC products?
- 3.6 grams (Correct answer)
- 7.5 grams
- 9.0 grams
- 12.0 grams
Correct answer: 3.6 grams
CMEA limits retail sales of ephedrine, pseudoephedrine, and phenylpropanolamine to 3.6 grams per day per purchaser.
Question 3: A pharmacist receives a faxed prescription for a Schedule II controlled substance. Under what circumstance may the pharmacist dispense based on the fax alone?
- Never; the original written prescription must be presented before dispensing in all cases.
- When the patient is in a long-term care facility (LTCF). (Correct answer)
- When the prescriber faxes from a hospital.
- When the prescriber is out of state.
Correct 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.
Question 4: What labeling is required on a repackaged drug distributed by a hospital pharmacy to a patient for home use?
- The label must comply with state outpatient prescription labeling requirements. (Correct answer)
- No labeling is required because it originated in an institutional setting.
- Only the drug name and strength are required.
- The original manufacturer's labeling is sufficient.
Correct 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.
Question 5: Which auxiliary label is most appropriate to affix to a prescription for tetracycline?
- Take with food or milk.
- Avoid prolonged exposure to sunlight. (Correct answer)
- Shake well before use.
- May cause drowsiness — use caution when driving.
Correct answer: Avoid prolonged exposure to sunlight.
Tetracyclines cause photosensitivity, making a sun-exposure warning the most clinically relevant auxiliary label.
Question 6: A pharmacist is dispensing methadone for opioid use disorder treatment. Which entity must be licensed to dispense methadone for this specific indication?
- Any DEA-registered retail pharmacy.
- Only a DEA-registered Opioid Treatment Program (OTP). (Correct answer)
- A hospital pharmacy with a Schedule II DEA registration.
- Any pharmacy that has completed DEA Form 224.
Correct 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.
Question 7: What is the beyond-use date (BUD) for a non-sterile compounded preparation containing water when no stability data are available?
- 7 days refrigerated
- 14 days refrigerated (Correct answer)
- 30 days at room temperature
- 6 months refrigerated
Correct answer: 14 days refrigerated
USP <795> specifies a default BUD of 14 days when refrigerated for non-sterile aqueous preparations lacking stability data.
MPJE Dispensing and Labeling 3
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?