Patient Package Insert (PPI)

[FDA] Patient labeling that is part of the FDA-approved prescription drug labeling. PPIs are developed by the manufacturer, approved by the FDA, and are required to be dispensed with specific products or classes of products (i.e., oral contraceptives and estrogen-containing products) (see, 21 CFR 310.501 and 21 CFR 310.515).

Source: Learn About Your Medicines


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