What is a characteristic of a misbranded drug?

A misbranded drug is specifically defined by its failure to meet labeling requirements outlined by regulatory authorities. When a drug does not contain accurate or complete information on its labeling, it is termed misbranded. This may include not having adequate directions for use, failing to include the correct active ingredient information, or not displaying necessary warnings.

In contrast, the characteristics of options like being manufactured in a licensed facility or complying with safety regulations do not inherently determine whether a drug is misbranded. A drug could be manufactured properly yet still be misbranded if its labeling is incorrect. Similarly, the classification as over-the-counter does not relate to whether a drug is misbranded; instead, it refers to the status of the drug in terms of accessibility to consumers without a prescription.

Thus, the hallmark characteristic of a misbranded drug is that it is not labeled with the correct information, which aligns with the definition provided by the Federal Food, Drug, and Cosmetic Act.