MPJE General 3 — Questions and Answers
Question 1: Under the Combat Methamphetamine Epidemic Act, the daily purchase limit for pseudoephedrine is:
- 2.4 grams
- 3.6 grams (Correct answer)
- 7.5 grams
- 9.0 grams
Correct answer: 3.6 grams
CMEA limits pseudoephedrine purchases to 3.6 grams per day and 9 grams per 30-day period.
Question 2: A pharmacist who breaches patient confidentiality without authorization may face disciplinary action under:
- The Controlled Substances Act only
- State pharmacy practice acts and HIPAA (Correct answer)
- The Federal Food, Drug, and Cosmetic Act only
- Medicare Part D regulations only
Correct answer: State pharmacy practice acts and HIPAA
Unauthorized disclosure of patient information can trigger both state pharmacy board sanctions and federal HIPAA penalties.
Question 3: Which of the following best defines 'adulteration' of a drug product under the FD&C Act?
- Selling a drug without FDA approval
- A product that fails to meet established quality, strength, or purity standards (Correct answer)
- Marketing a drug for an unapproved indication
- Dispensing a drug without a valid prescription
Correct answer: A product that fails to meet established quality, strength, or purity standards
Under the FD&C Act, adulteration refers to a drug that does not meet quality, strength, purity, or composition standards.
Question 4: A pharmacist may dispense a Schedule III controlled substance refill up to how many times within 6 months of the original prescription date?
- No refills are permitted
- Up to 3 times
- Up to 5 times (Correct answer)
- Up to 12 times
Correct answer: Up to 5 times
Schedule III and IV controlled substances may be refilled up to 5 times within 6 months of the original issue date.
Question 5: Under the Poison Prevention Packaging Act, child-resistant containers are NOT required for which of the following?
- Oral solid medications dispensed in quantities greater than 50
- Nitroglycerin sublingual tablets (Correct answer)
- Oral antibiotic suspensions
- Oral iron supplements containing 250 mg or more of elemental iron
Correct answer: Nitroglycerin sublingual tablets
Nitroglycerin sublingual tablets are specifically exempt from PPPA child-resistant packaging requirements.
Question 6: The 'corresponding responsibility' doctrine under federal controlled substance law holds that:
- Manufacturers are responsible for all downstream drug diversion
- A pharmacist shares responsibility for ensuring a controlled substance prescription is issued for a legitimate medical purpose (Correct answer)
- DEA must investigate every suspicious order before a pharmacy can dispense
- Prescribers bear sole legal liability for illegitimate prescriptions
Correct answer: A pharmacist shares responsibility for ensuring a controlled substance prescription is issued for a legitimate medical purpose
Corresponding responsibility means a pharmacist who knowingly fills an illegitimate controlled substance prescription shares legal liability with the prescriber.
Question 7: A pharmacy that compounds sterile preparations for office use by practitioners must comply with which USP chapter?
- USP <795>
- USP <797> (Correct answer)
- USP <800>
- USP <1160>
Correct answer: USP <797>
USP <797> establishes standards for sterile compounding to minimize risks of contamination, infection, and other harm.
MPJE General 3
Under the Combat Methamphetamine Epidemic Act, the daily purchase limit for pseudoephedrine is: