Draft Guidance for Industry on Labeling Over-the-Counter Human Drug Products; Questions and Answers; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Labeling OTC Human Drug Products--Questions and Answers."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 to implement the agency's regulation on standardized content and format requirements for the labeling of OTC drug products. This draft guidance discusses labeling questions that have been frequently asked by manufacturers, packers, and distributors in implementing the new requirements. The labeling examples in this draft guidance show various format and content features and suggest how OTC drug monograph labeling information finalized before the new requirements can be converted to the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.