MPJE Drug Substitution and Generic Drug Laws 2

Question 1

ANDA is the abbreviation for:

Accepted Answer

Abbreviated New Drug Application

Answer

ANDA stands for Abbreviated New Drug Application, the regulatory pathway generic manufacturers use to obtain FDA approval without conducting full clinical trials.

Question 2

A 'B' rating (e.g., BX, BN) in the Orange Book indicates that the drug product:

Accepted Answer

Is not currently considered therapeutically equivalent to other products with the same active ingredient

Answer

A 'B' rating indicates FDA does not currently consider the product therapeutically equivalent to other drugs with the same active ingredient due to actual or potential bioequivalence issues.

Question 3

Therapeutic substitution differs from generic drug substitution because therapeutic substitution:

Accepted Answer

Involves replacing the prescribed drug with a chemically different drug that has similar therapeutic effects

Answer

Therapeutic substitution replaces a prescribed drug with a chemically different entity having similar therapeutic effects, whereas generic substitution replaces it with the same chemical entity from a different manufacturer.

Question 4

Under most state drug product selection laws, when a pharmacist substitutes a generic drug, the patient must be:

Accepted Answer

Notified of the substitution and given the opportunity to request the brand-name product

Answer

Most state laws require pharmacists to notify patients of generic substitution and offer them the option to receive the brand-name drug, protecting patient autonomy.

Question 5

The 'first-to-file' provision of the Hatch-Waxman Act rewards the first generic manufacturer to challenge a brand drug patent with:

Accepted Answer

180 days of marketing exclusivity before other generics may enter the market

Answer

Under Hatch-Waxman, the first generic manufacturer to file a Paragraph IV patent certification receives 180 days of marketing exclusivity as an incentive to challenge brand drug patents.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE Drug Substitution and Generic Drug Laws 2