Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products

The Food and Drug Administration (FDA) is issuing an interim final rule to codify the provisions of the proposed rule entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" (69 FR 21778, April 22, 2004) (the toll-free number proposed rule or proposed rule) that, under the Food and Drug Administration Amendments Act of 2007 (FDAAA), became effective by operation of law on January 1, 2008. This interim final rule requires the addition of a statement on the labeling of certain human drug products for which an application is approved under the Federal Food, Drug, and Cosmetic Act (the act). The added statement includes a toll- free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). As mandated by FDAAA, this interim final rule does not apply to over-the-counter drug products approved as new drugs under the act if the product packaging includes a manufacturer's or distributor's toll-free number for reporting complaints.