South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Under which condition is a drug considered misbranded?

1. It comes from a registered establishment

2. It does not comply with REMS

3. It is stored improperly

4. It is sold without a prescription

The correct answer is: It does not comply with REMS

A drug is considered misbranded when it does not comply with Risk Evaluation and Mitigation Strategies (REMS) because these are safety measures designed to manage known or potential serious risks associated with certain medications. REMS requirements may include elements to assure safe use, such as required patient monitoring, specific prescribing practices, or additional education for patients and providers. If a drug fails to meet these compliance standards, it can pose significant health risks, and thus it is classified as misbranded. In contrast, the other conditions listed do not necessarily classify a drug as misbranded according to FDA regulations. While improper storage of a drug can affect its effectiveness or safety, it does not align with the specific criteria for misbranding, which primarily focuses on labeling and promotional practices. Similarly, a drug being sold without a prescription does not inherently make it misbranded; certain drugs are designated for over-the-counter use and may legally be sold without a prescription. Lastly, a drug originating from a registered establishment alone does not determine its branding status; it must also adhere to required labeling and other regulatory standards to avoid being classified as misbranded.