When is a medication guide required to be dispensed by the FDA?

A medication guide is required to be dispensed when the FDA determines that it contains information essential for the safe and effective use of a medication, particularly information about serious adverse effects or potential risks. This requirement is crucial because it ensures that patients receive important safety information that may not be sufficiently covered in standard labeling. The FDA specifically mandates medication guides for certain high-risk medications or those associated with serious adverse effects to promote patient safety and to facilitate informed decision-making regarding their treatment.

The other options do not align with the regulations surrounding medication guides. For instance, over-the-counter medications typically do not require medication guides, as they fall under different labeling requirements. Similarly, the requirement is not exclusive to medications prescribed in hospitals; medication guides can apply to outpatient prescriptions when there are significant safety concerns. Lastly, not every prescription dispensed necessitates a medication guide, as this is specifically determined by the FDA based on the particular medication's risks and benefits.