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Misbranding

Meaning

Misbranding, in the context of pharmaceutical and hormonal products, is a serious regulatory violation defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act) that pertains to false, misleading, or inadequate labeling of a drug product. A drug is considered misbranded if its labeling is deceptive, if it fails to bear adequate directions for use, or if it omits necessary warnings or contraindications. For compounded hormonal preparations, misbranding often involves making unsubstantiated therapeutic claims or failing to include required information about the active ingredients and dosage. This is a significant concern for patient safety and regulatory compliance.