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

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?

Accepted Answer

Sublingual nitroglycerin tablets

Answer

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:

Accepted Answer

3 years

Answer

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?

Accepted Answer

Dispensing only through certified pharmacies or healthcare settings

Answer

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?

Accepted Answer

3.6 grams

Answer

The CMEA limits pseudoephedrine sales to 3.6 grams per day per purchaser.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE Federal 3