A patient package insert (PPI) is required for which of the following medications?

Federal regulations require a Patient Package Insert (PPI) to be dispensed with oral contraceptives and with estrogen-containing products. The regulation specifies that a PPI must be provided with each prescription and refill in the outpatient setting and with the first dose and at least every 30 days in institutional settings. This requirement applies specifically to oral contraceptives, not broadly to androgens, corticosteroids, or oral chemotherapy (which more commonly require a Medication Guide, not a PPI).

References (Pharmacy Technician documents/Study Guides):

• 21 CFR 310.501 (Patient package inserts for oral contraceptives).

• 21 CFR 310.515 (Patient package inserts for estrogens).

• PTCB/ExCPT Exam Guides: Patient information requirements (PPI vs. Medication Guide).