Final answer:
An expired drug product is considered adulterated and misbranded because its safety and efficacy may be compromised, and its labeling may no longer be accurate. The mention of generic drugs and FDA standards relates to the importance of proper regulation to prevent medical and environmental issues.
Step-by-step explanation:
An expired drug product in a manufacturer's bottle is considered both adulterated and misbranded. Adulteration refers to the degradation of the quality and safety of the drug, which can happen after the expiration date as the drug may no longer have the same efficacy or can potentially be harmful. Misbranding involves incorrect or misleading labeling, and an expired drug product may no longer have accurate labeling regarding its efficacy and safety. This ties closely with the concept of generic drugs, which are equivalent to brand-name drugs whose patents have expired, and are typically less expensive and manufactured by different companies after receiving FDA approval via an Abbreviated New Drug Application (ANDA).
In the 1990s, the procedures used by the FDA to approve generic drugs came under scrutiny during a major scandal involving allegations of corruption and preferential treatment towards certain generic pharmaceutical companies. It is crucial for drug manufacturers to comply with FDA regulations to ensure that medications are safe for public consumption and to prevent incidents like the generic drug scandal. Moreover, the improper disposal of expired or unused drugs can lead to environmental pollution, highlighting the importance of appropriate waste management for pharmaceutical products.