NAPLEX (North American Pharmacist Licensure Examination) Practice Exam

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What does the Orange Book (FDA) list?

  1. Approved drugs that can be interchanged with generics

  2. Biological drug products

  3. Drug pricing information

  4. Regulatory and business development references

The correct answer is: Approved drugs that can be interchanged with generics

The Orange Book, published by the FDA, lists approved drugs that can be interchanged with generics. This book provides information about drug products approved on the basis of safety and effectiveness by the FDA. It includes therapeutic equivalence evaluations, which are used by healthcare professionals to determine whether one drug product can be substituted for another. Therefore, option A is correct. Biological drug products are usually listed in the Purple Book, not the Orange Book. Drug pricing information is typically not included in the Orange Book, and regulatory and business development references are also not the main focus of the Orange Book.