What does a "B rating" in the Orange Book indicate?

A "B rating" in the Orange Book signifies that a drug is not therapeutically equivalent to other pharmaceutical products. This designation indicates that while a generic version of a drug may not be identical to its brand-name counterpart in terms of efficacy and safety, it does not imply that it is completely ineffective or problematic.

The Orange Book, officially known as the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, uses a coding system to help pharmacists and healthcare providers determine whether it is appropriate to substitute one drug for another. A "B rating" suggests that there may be significant differences in characteristics such as formulation or delivery system, which could affect how the medication works in patients.

This classification is critical for ensuring that substitutions made in a pharmacy setting do not compromise treatment outcomes or patient safety. Understanding these ratings helps healthcare professionals make informed decisions regarding medication therapy management.