Most drugs used in the care of children have never had appropriate studies conducted by the manufacturer which fulfill Food and Drug Administration requirements necessary to be included in the 'indications' portion of the package insert. Any use not described in the indications of the package insert is considered 'off-label'. A number of editorials and hard work by many individuals have all resulted in new legislation that hopefully will start to make the necessary changes in drug development. This paper will review the pertinent issues.
