West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

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Study for the West Virginia MPJE Exam. Includes flashcards and multiple-choice questions, each with hints and explanations. Prepare effectively for your pharmacy law exam!

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True or False: A grandfathered unapproved drug will have an NDC number and will be listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

False, it will have an NDC number but will not be listed in the Orange Book
False, it will not have an NDC number and will be listed in the Orange Book
True, it will have an NDC number and be listed in the Orange Book
True, it will not have an NDC number but will be listed in the Orange Book

The correct answer is: False, it will have an NDC number but will not be listed in the Orange Book

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.