What document is required by the FDA to be dispensed with oral contraceptives?

• A. Medication Guide
• B. Patient Package Insert (PPI)
• C. Informed Consent Form
• D. Prescription Label

Answer: (B)

The required document is the Patient Package Insert. This insert provides important, patient-friendly information about oral contraceptives—how to use them safely, who should not use them (contraindications), and the risks (such as blood clots or stroke in certain individuals). It also covers what to do if a dose is missed and guidance if pregnancy occurs, helping patients make informed decisions and use the medication correctly. While other patient information tools exist (like Medication Guides) for many prescription drugs and the prescription label communicates dosing, the FDA-specific requirement tied to oral contraceptives is the PPI. An Informed Consent Form isn’t the standard FDA document for this purpose, and the label alone does not replace the PPI.