Is the Orange Book considered federal law?

The Orange Book, officially known as "Approved Drug Products with Therapeutic Equivalence Evaluations," is published by the FDA and serves as a reference guide for pharmacists and healthcare providers regarding drug products that have been approved for safety and effectiveness. It provides information about which generic drugs are considered therapeutically equivalent to brand-name medications.

While the Orange Book is highly respected and serves as an important resource in pharmacy practice, it is not federal law; it does not possess the authority of a binding regulation or statute. Instead, it guides healthcare professionals in making informed decisions about drug substitutions and therapies.

Other options imply varying degrees of legal authority that the Orange Book does not possess. It is crucial to understand that while it can influence practices and is utilized to ensure compliance with federal guidelines, its function remains that of a guide rather than a regulation mandating specific actions.