What does labeling require if a generic drug is substituted for a brand?

When a generic drug is substituted for a brand-name drug, proper labeling is crucial to ensure that patients are informed about the medication they are receiving. The correct choice emphasizes that the label must include the manufacturer's name of the generic drug as well as a note indicating that a substitution has taken place. This is important for several reasons:

1. Patient Safety: Patients should be aware of the specific manufacturer of the medication to acknowledge any variances in drug formulation, which could affect efficacy or tolerability.

2. Transparency: Noting that a substitution has occurred prevents confusion and helps maintain trust in the healthcare system. Patients need to know they are receiving a different product than originally prescribed.

3. Regulatory Compliance: Pharmacists are required by law to provide this information to ensure compliance with state and federal regulations, which mandate clear communication about substitutions.

In this context, the other choices do not adequately serve the purpose of ensuring patient safety and compliance with legal requirements regarding generic drug substitutions. A note about the drug's color and shape, or just listing the brand name, does not provide sufficient information about who manufactured the drug or that a substitution has occurred, which are critical details for the patient. Additionally, a healthcare provider's full contact