Labeling of Nonprescription Human Drug Products Marketed w/o an Approved App as Required by the Dietary Supp & Nonpresription Drug Consumer Protection Act

This information collection supports implementation of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) (Pub. L. 109-462). The Public Law added section 502(x) to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(x)), requiring the label of a nonprescription drug product marketed without an approved application in the United States to include a domestic address or domestic telephone number through which a manufacturer, packer, and distributor may receive a report of a serious adverse event associated with its product(s).

The latest form for Labeling of Nonprescription Human Drug Products Marketed w/o an Approved App as Required by the Dietary Supp & Nonpresription Drug Consumer Protection Act expires 2022-07-31 and can be found here.