West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam 2026 - Free MPJE Practice Questions and Study Guide

The statement is false because a grandfathered unapproved drug does indeed have an NDC (National Drug Code) number, as NDC numbers are assigned to all drugs marketed in the United States, regardless of their approval status. However, these unapproved drugs are not listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, because they have not undergone the same rigorous approval process that approved drugs have. The Orange Book only lists drugs that have received FDA approval and are considered therapeutically equivalent to one another.

This context clarifies why the choice indicating that a grandfathered unapproved drug will have an NDC number but will not appear in the Orange Book is correct. Choices suggesting that it would either lack an NDC number or be included in the Orange Book do not accurately reflect the regulatory framework regarding grandfathered drugs.