A drug product consisting of tablets may be declared misbranded under which guideline?

A drug product, including tablets, would be considered misbranded if it does not meet specific regulatory standards, particularly regarding labeling. In this context, when a drug product fails to meet assay limits, it indicates that the actual amount of the active ingredient does not conform to the specifications outlined on the label or in regulatory standards. This discrepancy could significantly affect the safety and efficacy of the medication, thereby misleading consumers and healthcare professionals regarding the product's potency.

Assay limits are critical to ensuring that each dose contains the appropriate amount of medication to achieve the desired therapeutic effect. If the tables do not meet these limits, they would not only be failing to provide the stated benefits but might also increase the risk of adverse effects or treatment failures, leading to the conclusion that such a product is misbranded.

Other options, while they may indicate potential issues with the product, do not specifically relate to the critical principles governing accurate labeling and content of active ingredients, which are paramount in regulating drug products.