What is the name of the leaflet that the FDA requires to be dispensed with every prescription?

The correct answer is the Patient Package Insert. This is a specific leaflet provided to patients that contains information about the medication they are prescribed, including its uses, potential side effects, drug interactions, and proper usage instructions. The FDA mandates that this information be provided for certain prescription medications, particularly those that pose significant risks to patients.

The purpose of the Patient Package Insert is to ensure that patients receive essential information that can aid in their understanding of the drug's therapeutic use and safety profile. It supports informed decision-making regarding their therapy, fostering improved communication between the healthcare provider and the patient.

While Medication Guides are also important informational pamphlets provided for certain medications and serve a similar purpose, they are not required for every prescription. The Patient Package Insert has different regulatory requirements and is tied to the distribution and use of specific classes of drugs, ensuring patients have access to the necessary information consistently. Other choices such as Label Insert and Pharmacist's Information Sheet do not have the same formal recognition or requirement for distribution with every prescription as the Patient Package Insert does.