Arizona MPJE (Pharmacy Jurisprudence) Practice Exam 2026 - Free Pharmacy Law Practice Questions and Study Guide

A prescription-only drug is considered misbranded if it does not bear the statement "Rx only." This labeling requirement is established to clearly indicate to all parties—patients, pharmacists, and healthcare providers—that the drug is intended to be dispensed only with a prescription from a licensed health professional. This designation helps ensure that the medication is used safely and appropriately, as these drugs often have specific risks, dosages, or contraindications that require professional oversight.

The presence of the statement "Rx only" is crucial for compliance with regulations set forth by the Food and Drug Administration (FDA) and state pharmacy laws. Without this statement, patients may inadvertently assume they can obtain the medication without a prescription, which could lead to misuse or harmful consequences. Hence, the absence of the "Rx only" labeling is the reason why a prescription-only drug would be classified as misbranded prior to dispensing.