MPJE Federal 3

Question 1

Under the Federal Food, Drug, and Cosmetic Act (FDCA), which of the following labeling statements is required on all prescription drug products?

Accepted Answer

"Caution: Federal law prohibits dispensing without a prescription"

Answer

"Keep out of reach of children"

Answer

"Not for resale"

Answer

"Shake well before use"

Question 2

Under the Poison Prevention Packaging Act (PPPA), which of the following products is EXEMPT from child-resistant packaging requirements?

Accepted Answer

Sublingual nitroglycerin tablets

Answer

Oral prescription drugs

Answer

Oral liquid controlled substances

Answer

OTC aspirin in quantities greater than 1 g

Question 3

The Drug Supply Chain Security Act (DSCSA) requires that pharmacies maintain transaction records for prescription drug products for a minimum of:

Accepted Answer

3 years

Answer

1 year

Answer

2 years

Answer

6 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?

Accepted Answer

Dispensing only through certified pharmacies or healthcare settings

Answer

Monthly urine drug screening of all patients

Answer

A mandatory generic substitution program

Answer

DEA co-signature on all prescriptions

Question 5

The Combat Methamphetamine Epidemic Act (CMEA) limits the sale of pseudoephedrine to no more than how many grams per day per customer?

Accepted Answer

3.6 grams

Answer

2.4 grams

Answer

7.5 grams

Answer

9 grams

Question 6

Which federal law established the requirement for Medication Guides (MedGuides) to be dispensed with certain prescription drugs?

Accepted Answer

Food, Drug, and Cosmetic Act as amended with REMS authority

Answer

Omnibus Budget Reconciliation Act (OBRA-90)

Answer

FDA Modernization Act (FDAMA)

Answer

Kefauver-Harris Amendment

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?

Accepted Answer

Evaluation for therapeutic duplication, drug-disease contraindications, and incorrect dosage

Answer

Review of the patient's credit history for billing purposes

Answer

Mandatory consultation with the prescriber before dispensing any new medication

Answer

Verification of the patient's insurance eligibility