What characterizes a drug as misbranded?

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A drug is characterized as misbranded when its labeling is false, misleading, or incomplete. This definition centers on the accuracy and clarity of the information provided on the drug's packaging. If a label does not provide truthful information or fails to adequately inform healthcare professionals and consumers about the contents, uses, safety, or efficacy of the drug, it can lead to misunderstandings and inappropriate use, thereby posing potential risks to public health. Therefore, maintaining truthful and comprehensive labeling is crucial in ensuring that drugs are marketed safely and effectively.

In contrast, the other options focus on different aspects of drug regulation. For instance, a drug containing a higher potency than listed would relate more to its quality or safety rather than misbranding specifically. Clear and informative labeling would not characterize a drug as misbranded; instead, it would indicate proper compliance with labeling regulations. Lastly, being manufactured under cGMP (current Good Manufacturing Practices) concerns the production quality and standards rather than the labeling itself. Thus, the identification of a drug as misbranded predominantly hinges on deceptive or incomplete labeling.

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