Federal Register -Orphan Drug Release

    HRSA has released its final ruling in the Federal Registry regarding  the use of Orphan Drugs in the 340B discount drug program.

    The link below can be used to read the federal register notice containing the final ruling on the use of the Orphan drug list within the 340B program.  Use of these drugs is outlined to exclude use for specific disease states that provided the classification , “Orphan Drug”.  This status is designated for those disease state where 200,000 individuals or less effected.

    http://www.gpo.gov/fdsys/pkg/FR-2013-07-23/pdf/2013-17547.pdf

    Much discussion regarding this ruling has been taking place in Washington.

    The letter from Senator Hatch to HRSA  regarding his review of the issue is provided below.

    http://www.snhpa.org/public/documents/pdfs/Letter_Final_Rule_Orphan_Drugs_340B.PDF