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

The Food and Drug Administration (FDA) is issuing a final rule that confirms the interim final rule entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" (73 FR 402, January 3, 2008) (interim final rule) and responds to comments submitted in response to the request for comments in the proposed rule of the same title (69 FR 21778, April 22, 2004) (proposed rule). This final rule affirms the interim final rule's requirement for the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the act). The 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). This final rule also affirms the interim final rule's addition of new part 209 to the regulations requiring distribution of the side effects statement. This final rule implements provisions of the Best Pharmaceuticals for Children Act (the BPCA) and the Food and Drug Administration Amendments Act of 2007 (FDAAA).