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 Red Book

Answer

The Green Book

Answer

The Blue Book

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

The drug has known bioequivalence problems

Answer

The drug is approved only for OTC use

Answer

The drug has not yet been evaluated for therapeutic equivalence

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

The prescriber verbally approves the substitution at the time of dispensing

Answer

The generic is manufactured domestically

Answer

The patient has previously received the generic version

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

New clinical studies showing independent safety and efficacy

Answer

A novel molecular structure differing from the brand

Answer

Manufacturing facilities separate from the brand manufacturer

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

Use professional judgment to select the most cost-effective product

Answer

Dispense directions in written form only, without verbal counseling

Answer

Obtain prior authorization from the payer before dispensing

Question 6

The term 'bioequivalent' means that the generic drug product:

Accepted Answer

Delivers the same amount of active ingredient to the bloodstream at approximately the same rate as the reference product

Answer

Has the identical physical appearance as the brand-name drug

Answer

Is manufactured by the same pharmaceutical company as the brand

Answer

Contains identical inactive (excipient) ingredients as the brand-name drug

Question 7

Which legislation established the current Abbreviated New Drug Application (ANDA) process for generic drug approval?

Accepted Answer

Drug Price Competition and Patent Term Restoration Act of 1984

Answer

Food, Drug, and Cosmetic Act of 1938

Answer

Kefauver-Harris Amendment of 1962

Answer

Pure Food and Drug Act of 1906