Which statement signifies that a drug is misbranded?

A drug is classified as misbranded when its labeling fails to meet certain regulatory standards set forth by the FDA and other pertinent laws. Specifically, if the label does not contain all required information such as active ingredients, uses, warnings, directions for use, and any applicable meeting of regulatory affairs, it does not provide the necessary information for safe and effective use by consumers and healthcare professionals. This lack of essential information can lead to misuse or misunderstanding of the drug, prompting the classification of misbranding.

In contrast, a label that includes all the required information signifies compliance with regulations, while certification by the FDA indicates that the drug meets safety and efficacy standards. Moreover, the origin of manufacturing does not inherently relate to whether the drug is misbranded; misbranding focuses primarily on labeling accuracy and completeness rather than manufacturing location.