Regulatory Affairs Certification (RAC) Practice Exam

In order to be approved by FDA, a generic drug must be therapeutically equivalent to the branded product EXCEPT for:

1. Dosage Form

2. Route of Administration

3. Labeling

4. Inactive Ingredients

The correct answer is: Inactive Ingredients

For a generic drug to gain approval from the FDA, it must demonstrate therapeutic equivalence to its branded counterpart, which means it should have the same efficacy and safety profile. However, when it comes to inactive ingredients, the FDA allows some flexibility. Inactive ingredients do not need to be identical between the branded drug and its generic version as long as they do not significantly affect the therapeutic outcome or the drug's performance. Active ingredients and their formulations must be the same, and the dosage form, route of administration, and labeling must also align closely with the branded drug. Inactive ingredients can differ, allowing manufacturers to utilize different but acceptable substances that fulfill the same role in the drug formulation. This enables generic manufacturers to leverage more cost-effective alternatives and innovate while ensuring the overall therapeutic efficacy of the drug remains intact. Hence, the allowance for variability among inactive ingredients is a crucial factor for generic drug approval.