True or False: If the established name is not on a manufacturer label, it is considered misbranded.

The statement is true because the law requires that the established name of a drug must appear on the label of the product. The absence of the established name can lead to confusion and misidentification, which directly affects the proper use and safety of the medication. Misbranding occurs when a product is not labeled according to the standards set forth by the relevant authorities, including the Food and Drug Administration (FDA) and other regulatory agencies.

When a medication lacks its established name, it may not be easily recognized by healthcare professionals or patients, thereby compromising patient care. This is crucial in ensuring that individuals receive the correct medication for treatment. Therefore, if the established name is missing from the label of a medication, it is categorized as misbranded, fulfilling the criteria for misbranding as laid out in the applicable regulations.