What triggers the requirement for Patient Package Inserts (PPI) to be dispensed?

The requirement for Patient Package Inserts (PPIs) is triggered by both new prescriptions and refills. The purpose of the PPI is to inform patients about the specifics of their medications, including potential side effects, risks, and proper usage. This information is particularly critical for medications that are subject to stricter safety monitoring, such as estrogens and oral contraceptives.

By providing a PPI with each new prescription and refill, healthcare professionals ensure that patients receive up-to-date information about their medication each time they obtain it, allowing for informed decision-making about their treatment. This practice underscores the importance of patient education and safety when it comes to medication management, particularly for drugs that may have significant side effects or require careful patient adherence to treatment guidelines.

In contrast, the other options incorrectly suggest limitations either by restricting the distribution of PPIs to only new prescriptions or to certain medications. There are also no scenarios within the regulations where PPIs are entirely exempt, reinforcing the essential role they play in patient safety across multiple refills.