FDA: Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers

This document is intended to assist industry in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act. These requirements apply to manufacturers, packers, and distributors of nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application.