Question

What conditions must be met by a generic equivalent drug product in order for the product to be eligible for generic substitution?

Answer 1

A generic equivalent drug product must be interchangeable, therapeutically equivalent, and meet the same quality standards as the brand-name drug to be eligible for generic substitution.

Step-by-step explanation:

In order for a generic equivalent drug product to be eligible for generic substitution, it must meet certain conditions:

1. The generic drug must be interchangeable with the original brand-name drug, meaning it has the same active ingredients and is absorbed by the body in the same way.
2. The generic drug must be therapeutically equivalent to the original brand-name drug, meaning it produces the same effects in terms of safety, effectiveness, and dosage.
3. The generic drug must meet the same rigorous standards of quality and manufacturing as the brand-name drug.

These conditions are established by the U.S. Food and Drug Administration (FDA) to ensure that generic drugs are safe and effective alternatives to brand-name drugs.