What action must be taken if a drug is found to be misbranded?

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A drug is considered misbranded when its labeling is false or misleading in any way, or if it fails to meet the requirements set by the FDA regarding its labeling. When a drug is found to be misbranded, it poses a risk to patient safety due to the potential for incorrect usage or misunderstanding of the product's indications, contraindications, and proper administration.

To ensure patient protection and comply with federal regulations, the correct action is that the misbranded drug must not be redispensed. This precaution prevents patients from receiving products that could lead to harmful health outcomes or misconceptions about the drug's proper use. By ensuring that misbranded drugs are not available for patient use, pharmacists uphold their ethical responsibility to provide safe and accurate medication therapy to their patients.

Maintaining the integrity of drug labeling and ensuring that all medicines dispensed are correctly identified and communicated to patients is paramount in pharmacy practice. This commitment to safety is why regulations explicitly state that misbranded drugs cannot be redistributed or sold until they are properly labeled.

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