Guidance for Industry on Labeling Over-the-Counter Human Drug Products-Questions and Answers; Availability

Résumé

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Labeling OTC Human Drug Products--Questions and Answers." This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products in complying with the agency's regulation on standardized content and format requirements for the labeling of OTC drug products. This guidance primarily discusses labeling questions that have been frequently asked by manufacturers, packers, and distributors relating to these requirements. The labeling examples in this guidance show various format and content features and suggest how OTC drug monograph labeling information finalized before the new requirements can be converted to the new format. This guidance finalizes the draft guidance of the same name published January 13, 2005 (70 FR 2415).