MPJE Drug Substitution and Generic Drug Laws 3

Question 1

Which of the following statements about an 'AA' rating in the Orange Book is TRUE?

Accepted Answer

The drug is a conventional dosage form with no bioequivalence concerns and no known equivalent

Answer

The drug is therapeutically equivalent to multiple generic versions

Answer

The drug is approved only for abbreviated new drug applications

Answer

The drug has failed bioequivalence testing and requires reformulation

Question 2

Under state drug product selection laws, pharmacists are generally:

Accepted Answer

Permitted but not required to substitute a therapeutically equivalent generic

Answer

Required to substitute a generic drug in every case regardless of prescriber instructions

Answer

Prohibited from substituting any generic without DEA authorization

Answer

Required to obtain written patient consent before any generic substitution

Question 3

A prescription written with a brand name followed by the notation 'or equivalent' indicates:

Accepted Answer

The pharmacist may dispense a therapeutically equivalent generic product

Answer

The pharmacist must dispense the brand-name drug as written

Answer

The patient must approve any substitution in writing before it is made

Answer

The prescriber will contact the pharmacy to confirm the final product selected

Question 4

Which amendment to the Food, Drug, and Cosmetic Act first required manufacturers to prove both safety AND efficacy before marketing a new drug?

Accepted Answer

Kefauver-Harris Amendment of 1962

Answer

Durham-Humphrey Amendment of 1951

Answer

Food, Drug, and Cosmetic Act of 1938

Answer

Hatch-Waxman Act of 1984

Question 5

A 'BX' rating in the Orange Book indicates:

Accepted Answer

Data are insufficient to determine therapeutic equivalence at this time

Answer

The drug is therapeutically equivalent to the reference listed drug

Answer

The drug has been excluded permanently from generic substitution

Answer

The drug has demonstrated superior bioavailability compared to competitors

Question 6

Under the Hatch-Waxman Act, when a brand drug manufacturer receives a Paragraph IV certification from a generic applicant, it may:

Accepted Answer

File a patent infringement lawsuit within 45 days to trigger an automatic 30-month stay of generic approval

Answer

Immediately recall the brand-name product to prevent competition

Answer

Request FDA to permanently deny the generic application

Answer

File a citizen petition that automatically blocks the generic indefinitely

Question 7

When is a pharmacist generally NOT permitted to substitute a generic drug product?

Accepted Answer

When the prescriber has written 'Dispense as Written' or equivalent restrictive language

Answer

When the generic drug costs significantly less than the brand-name product

Answer

When the patient has a valid insurance prior authorization on file

Answer

When the drug appears on the payer's formulary preferred drug list