Which components must a label have to be considered NOT misbranded?

For a label to be considered not misbranded, it must contain specific information that provides essential details about the drug for safe use and identification. The correct answer acknowledges that both sets of information in options A and B are necessary components of a drug label.

In option A, including the drug name, drug strength, and lot number is crucial because it allows healthcare professionals and patients to identify the medication clearly, understand its potency, and trace its manufacturing batch. This can be vital in cases where there is a recall or adverse effects associated with a specific lot of a medication.

In option B, stating the manufacturer and the date of expiration is equally important. The manufacturer's name allows for accountability and tracing back to the source of the drug, ensuring that it meets quality standards. The expiration date informs users about the salvage date of the medication, which is critical for safety—medications that are used past their expiration can be ineffective or potentially harmful.

By recognizing that both sets of components are essential for accurate drug labeling, it is clear that a label fulfilling the criteria in both options is not misbranded, thereby justifying the selection of the combined option. The presence of both an informative drug label with key identifiers directly contributes to safe medication practices and helps to mitigate