South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is NOT a reason to issue a Supplemental NDA (SNDA)?

1. Change in labeling of an already marketed drug

2. Change in drug manufacturing location

3. Change in drug active ingredient

4. Change in production procedure

The correct answer is: Change in drug active ingredient

A Supplemental New Drug Application (SNDA) is used to request changes to an already approved drug's application. The types of modifications that can be submitted under an SNDA generally include changes in labeling, manufacturing processes, and production sites. A change in the active ingredient of a drug is distinct from these other modifications because this type of alteration constitutes a significant change to the drug's formulation. Such a change would typically require a brand new New Drug Application (NDA) since it affects the drug's fundamental attributes and potentially its safety and efficacy profile. In contrast, changes in labeling, manufacturing location, and production procedures do not inherently alter the fundamental characteristics of the drug itself and can be addressed through an SNDA. Understanding this distinction is crucial for pharmacy professionals to ensure compliance with regulatory requirements and maintain the integrity and safety of pharmaceutical products.