Washington Multistate Pharmacy Jurisprudence MPJE Practice Exam

What criteria must be met for generic substitution?

1. Same chemical entity, dosage form, bioequivalent, same AUC, and same Peak

2. Only cheaper than the prescribed brand

3. Available in stock

4. Approved by the patient

The correct answer is: Same chemical entity, dosage form, bioequivalent, same AUC, and same Peak

In order for generic substitution to occur, the generic medication must meet several criteria. These include being the same chemical entity as the brand name, having the same dosage form, being bioequivalent (meaning that it will have the same effects in the body), having the same area under the curve (AUC), and the same peak concentration. This means that the generic and brand name medications will essentially have the same composition and impact on the body. Option B is incorrect because cost is not the only criteria for generic substitution. Option C is incorrect because availability in stock does not affect the criteria for generic substitution. Option D is incorrect because the approval of the patient is not a criteria for generic substitution, although it is important for the patient to be informed and involved in their medication decisions. Therefore, option A is the correct answer as it includes all the necessary criteria for generic substitution to occur.