Guidance for Industry: Bar Code Label Requirements, Questions and Answers. Revision 1

摘要

FDA regulations require that certain human drug and biological product labels contain a bar code consisting of, at a minimum, the National Drug Code (NDC) number (21 CFR 201.25). This guidance provides questions and answers relating to how the bar code label requirements apply to specific products or circumstances. The questions are based on those posed to the Agency since the final rule published in February 2004. This guidance, which is a revision of the April 2006 version, contains input from the Center for Biologics Evaluation and Research. FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.