Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

When is a drug considered misbranded?

1. When it is expired

2. When it is proven to be effective

3. When it is dangerous to use as suggested by the labeling

4. When it is properly labeled

The correct answer is: When it is expired

A drug is considered misbranded when its labeling is found to be false or misleading in any way, or when it fails to include certain required information. The correct context for this question is that a drug can be misbranded if it presents dangers when used according to the labeling instructions, making that scenario a valid reason for misbranding. In this case, when a drug is dangerous to use as suggested by the labeling, it indicates that the labeling may not accurately reflect the risks associated with the drug or might fail to provide adequate warnings. This misrepresentation can lead to misuse or harm, which is a fundamental principle that governs drug labeling and safety regulations set forth by the FDA. Thus, a drug that is expired, while not safe for use, does not directly relate to misbranding as described in the regulatory framework. A drug being proven effective does not contribute to misbranding issues, as effectiveness is a separate matter from the labeling requirements that define misbranding. Properly labeled drugs, on the other hand, would not be categorized as misbranded.