MPJE Federal 3 — Questions and Answers
Question 1: Under the Federal Food, Drug, and Cosmetic Act (FDCA), which of the following labeling statements is required on all prescription drug products?
- "Keep out of reach of children"
- "Caution: Federal law prohibits dispensing without a prescription" (Correct answer)
- "Not for resale"
- "Shake well before use"
Correct answer: "Caution: Federal law prohibits dispensing without a prescription"
Federal law requires prescription drug labels to bear the legend 'Caution: Federal law prohibits dispensing without a prescription' (or equivalent Rx only statement).
Question 2: Under the Poison Prevention Packaging Act (PPPA), which of the following products is EXEMPT from child-resistant packaging requirements?
- Oral prescription drugs
- Sublingual nitroglycerin tablets (Correct answer)
- Oral liquid controlled substances
- OTC aspirin in quantities greater than 1 g
Correct answer: Sublingual nitroglycerin tablets
Sublingual nitroglycerin tablets are specifically exempted from child-resistant container requirements under the PPPA.
Question 3: The Drug Supply Chain Security Act (DSCSA) requires that pharmacies maintain transaction records for prescription drug products for a minimum of:
- 1 year
- 2 years
- 3 years (Correct answer)
- 6 years
Correct answer: 3 years
The DSCSA requires pharmacies to maintain transaction information, transaction history, and transaction statements for at least 3 years.
Question 4: Under FDA regulations, a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) may require which of the following?
- Monthly urine drug screening of all patients
- Dispensing only through certified pharmacies or healthcare settings (Correct answer)
- A mandatory generic substitution program
- DEA co-signature on all prescriptions
Correct answer: Dispensing only through certified pharmacies or healthcare settings
REMS with ETASU can restrict distribution to certified pharmacies or healthcare settings to manage serious drug risks.
Question 5: The Combat Methamphetamine Epidemic Act (CMEA) limits the sale of pseudoephedrine to no more than how many grams per day per customer?
- 2.4 grams
- 3.6 grams (Correct answer)
- 7.5 grams
- 9 grams
Correct answer: 3.6 grams
The CMEA limits pseudoephedrine sales to 3.6 grams per day per purchaser.
Question 6: Which federal law established the requirement for Medication Guides (MedGuides) to be dispensed with certain prescription drugs?
- Omnibus Budget Reconciliation Act (OBRA-90)
- FDA Modernization Act (FDAMA)
- Food, Drug, and Cosmetic Act as amended with REMS authority (Correct answer)
- Kefauver-Harris Amendment
Correct answer: Food, Drug, and Cosmetic Act as amended with REMS authority
FDA regulations under the FDCA authority (21 CFR 208) require Medication Guides for drugs with serious risks, and REMS authority formalized their role.
Question 7: Under the Omnibus Budget Reconciliation Act of 1990 (OBRA-90), which of the following is a required component of a pharmacist's prospective drug review for Medicaid patients?
- Review of the patient's credit history for billing purposes
- Evaluation for therapeutic duplication, drug-disease contraindications, and incorrect dosage (Correct answer)
- Mandatory consultation with the prescriber before dispensing any new medication
- Verification of the patient's insurance eligibility
Correct answer: Evaluation for therapeutic duplication, drug-disease contraindications, and incorrect dosage
OBRA-90 requires pharmacists to conduct prospective drug use review including screening for therapeutic duplication, drug-disease contraindications, incorrect dosage, and drug interactions.
MPJE Federal 3
Under the Federal Food, Drug, and Cosmetic Act (FDCA), which of the following labeling statements is required on all prescription drug products?