MPJE Drug Substitution and Generic Drug Laws

Question 1

What FDA publication identifies which generic drug products are therapeutically equivalent to their brand-name counterparts?

Accepted Answer

The Orange Book

Answer

The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is the FDA publication that identifies therapeutically equivalent generic drug products.

Question 2

What does an 'AB' rating in the FDA's Orange Book indicate about a generic drug product?

Accepted Answer

The drug is therapeutically equivalent to the reference listed drug

Answer

An 'AB' rating indicates the generic drug product is therapeutically equivalent to the reference listed drug, meaning it can be substituted without additional clinical evidence.

Question 3

Under most state drug product selection laws, a pharmacist may substitute a generic drug for a brand-name product when:

Accepted Answer

The generic has an 'AB' rating and no 'DAW' instruction appears on the prescription

Answer

Most state drug product selection laws allow substitution when the generic carries an 'AB' therapeutic equivalence rating and the prescriber has not restricted substitution via a 'dispense as written' instruction.

Question 4

Under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), a generic manufacturer must demonstrate:

Accepted Answer

Bioequivalence to the reference listed drug

Answer

The Hatch-Waxman Act established the ANDA pathway requiring generic manufacturers to demonstrate bioequivalence, eliminating the need for full new clinical trials.

Question 5

When a prescriber writes 'Dispense as Written' (DAW) on a prescription, the pharmacist must:

Accepted Answer

Dispense the brand-name drug exactly as written without generic substitution

Answer

A 'Dispense as Written' instruction obligates the pharmacist to dispense the specific brand-name product as written, overriding state drug product selection laws that would otherwise permit substitution.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE Drug Substitution and Generic Drug Laws