Preparation and maintenance of prescription drug labeling.

Abstract

This article describes procedures used to prepare and maintain prescription drug labeling beginning with a brief overview of the statutory and regulatory requirements. Discussed is the labeling format prescribed by FDA regulation and the type of information needed for the key labeling components. The article provides a description of typical company approaches for developing and approving the labeling text. Discussed are the multi-disciplinary groups responsible for preparing and approving the copy with comparison to an analogous multi-disciplinary group at the FDA which has responsibility for review and approval of labeling submitted with regulatory documents. Discussed also is the need for international labeling consistency for drugs which are marketed in countries other than the U.S. Reference is made to security considerations regarding the approved copy.