This document is intended to provide guidance on general principles for submitting information 2 on packaging materials used for human drugs and biologics. This guidance supersedes the fda 3 guideline for submitting documentation for packaging for human drugs and biologics, issued in february 1987 and the packaging policy statement issued in a letter to industry dated june 30, 1995 from the office of generic drugs. This guidance is not intended to describe the 4 information that should be provided about packaging operations associated with drug product manufacture.
