South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What must a misbranded drug include to avoid being classified as such?

1. Generic name

2. Instructions for off-label use

3. Name and location of the manufacturer

4. Prescription number

The correct answer is: Name and location of the manufacturer

A drug is considered misbranded if its labeling is false or misleading in any particular way. To avoid being classified as misbranded, it is essential that the drug include the name and location of the manufacturer. This requirement helps ensure that consumers and healthcare providers can identify who is responsible for the drug and where it is produced, thereby contributing to accountability and traceability in the pharmaceutical supply chain. This information is vital for safety reasons, as well as for addressing any potential issues related to recalls or adverse effects associated with the drug. The inclusion of the generic name would not necessarily prevent a drug from being misbranded, as other aspects of the labeling might still be misleading or inaccurate. Instructions for off-label use are not typically required in labeling and could also contribute to misbranding since they might not be approved by regulatory authorities. Lastly, a prescription number pertains to the individual dispensing record rather than the drug’s labeling, and it's not relevant to the classification of the drug itself. Therefore, the correct identification of the manufacturer and its location is crucial in maintaining proper labeling standards and ensuring that drugs are not misbranded.