Drug Substitution and Generic Drug Laws Flashcards
7 cards from real MPJE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Drug Substitution and Generic Drug Laws flashcards as text
Which of the following statements about an 'AA' rating in the Orange Book is TRUE?
Answer: The drug is a conventional dosage form with no bioequivalence concerns and no known equivalent
An 'AA' rating is assigned to conventional dosage forms that have no bioequivalence issues—these are typically products where there is no other marketed version to compare against.
Under state drug product selection laws, pharmacists are generally:
Answer: Permitted but not required to substitute a therapeutically equivalent generic
State drug product selection laws authorize pharmacists to substitute therapeutically equivalent generics but do not mandate it, and they preserve both prescriber and patient override rights.
A prescription written with a brand name followed by the notation 'or equivalent' indicates:
Answer: The pharmacist may dispense a therapeutically equivalent generic product
When a prescriber writes 'or equivalent,' it constitutes explicit consent for the pharmacist to substitute a therapeutically equivalent product as listed in the Orange Book.
Which amendment to the Food, Drug, and Cosmetic Act first required manufacturers to prove both safety AND efficacy before marketing a new drug?
Answer: Kefauver-Harris Amendment of 1962
The Kefauver-Harris Amendment of 1962 established the dual requirement that new drugs be proven both safe and effective, triggered by the thalidomide tragedy in Europe.
A 'BX' rating in the Orange Book indicates:
Answer: Data are insufficient to determine therapeutic equivalence at this time
A 'BX' rating means FDA currently lacks sufficient data to classify the drug as therapeutically equivalent, placing it in a 'B' category by default.
Under the Hatch-Waxman Act, when a brand drug manufacturer receives a Paragraph IV certification from a generic applicant, it may:
Answer: File a patent infringement lawsuit within 45 days to trigger an automatic 30-month stay of generic approval
Filing a patent infringement suit within 45 days of receiving a Paragraph IV certification triggers an automatic 30-month stay of FDA approval of the generic, allowing time to litigate the patent dispute.
When is a pharmacist generally NOT permitted to substitute a generic drug product?
Answer: When the prescriber has written 'Dispense as Written' or equivalent restrictive language
A pharmacist cannot substitute a generic when the prescriber has restricted substitution through 'Dispense as Written,' 'Brand Medically Necessary,' or equivalent notation, as prescriber authority overrides state substitution laws.