BCPS Regulatory Practice Test 2026 - Free BCPS Regulatory Practice Questions and Study Guide

Therapeutic equivalence decisions hinge on a single, authoritative reference from FDA. The primary source that lists approved drug products and their therapeutic equivalence evaluations is the Orange Book (officially titled Approved Drug Products with Therapeutic Equivalence Evaluations). It assigns codes to indicate whether a generic version is considered therapeutically equivalent to a brand-name product, guiding safe substitution in practice. An A-code means the generic is therapeutically equivalent and interchangeable; a B-code indicates it is not equivalent or not recommended for substitution. Pharmacists use this resource to determine when a generic can be substituted for a brand-name drug. Other color-named books cover topics like pricing or safety rather than therapeutic equivalence, so they do not serve this purpose.