MPJE Drug Substitution and Generic Drug Laws 1 — Questions and Answers
Question 1: What FDA publication identifies which generic drug products are therapeutically equivalent to their brand-name counterparts?
- The Orange Book (Correct answer)
- The Red Book
- The Green Book
- The Blue Book
Correct answer: The Orange Book
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?
- The drug is therapeutically equivalent to the reference listed drug (Correct answer)
- The drug has known bioequivalence problems
- The drug is approved only for OTC use
- The drug has not yet been evaluated for therapeutic equivalence
Correct answer: The drug is therapeutically equivalent to the reference listed drug
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:
- The generic has an 'AB' rating and no 'DAW' instruction appears on the prescription (Correct answer)
- The prescriber verbally approves the substitution at the time of dispensing
- The generic is manufactured domestically
- The patient has previously received the generic version
Correct answer: The generic has an 'AB' rating and no 'DAW' instruction appears on the prescription
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:
- Bioequivalence to the reference listed drug (Correct answer)
- New clinical studies showing independent safety and efficacy
- A novel molecular structure differing from the brand
- Manufacturing facilities separate from the brand manufacturer
Correct answer: Bioequivalence to the reference listed drug
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:
- Dispense the brand-name drug exactly as written without generic substitution (Correct answer)
- Use professional judgment to select the most cost-effective product
- Dispense directions in written form only, without verbal counseling
- Obtain prior authorization from the payer before dispensing
Correct answer: Dispense the brand-name drug exactly as written without generic substitution
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.
Question 6: The term 'bioequivalent' means that the generic drug product:
- Delivers the same amount of active ingredient to the bloodstream at approximately the same rate as the reference product (Correct answer)
- Has the identical physical appearance as the brand-name drug
- Is manufactured by the same pharmaceutical company as the brand
- Contains identical inactive (excipient) ingredients as the brand-name drug
Correct answer: Delivers the same amount of active ingredient to the bloodstream at approximately the same rate as the reference product
Bioequivalence requires that the generic product demonstrate the same pharmacokinetic profile—rate and extent of absorption—as the reference listed drug within FDA-accepted statistical limits.
Question 7: Which legislation established the current Abbreviated New Drug Application (ANDA) process for generic drug approval?
- Drug Price Competition and Patent Term Restoration Act of 1984 (Correct answer)
- Food, Drug, and Cosmetic Act of 1938
- Kefauver-Harris Amendment of 1962
- Pure Food and Drug Act of 1906
Correct answer: Drug Price Competition and Patent Term Restoration Act of 1984
The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) created the ANDA pathway, enabling generic drugs to gain approval through bioequivalence rather than full clinical trials.
MPJE Drug Substitution and Generic Drug Laws 1
What FDA publication identifies which generic drug products are therapeutically equivalent to their brand-name counterparts?