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Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma September 18, 2003 Elizabeth Callaghan Division of Blood Applications Revisions to Labeling and Storage Proposed rule published July 30, 2003 Main objectives:

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Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma

September 18, 2003

Elizabeth Callaghan

Division of Blood Applications


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Revisions to Labeling and Storage Blood Components, Including Source Plasma

  • Proposed rule published July 30, 2003

  • Main objectives:

    • Consolidate, simplify, and update container labels and instruction circular regulations

    • Remove inconsistencies with ISBT 128

    • Modify shipping and storage temperatures for frozen noncellular products


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Revisions to Labeling and Storage Blood Components, Including Source Plasma

  • Combined both WB and SP labeling requirements into one section of the CFR

  • “shall” to “must”

  • Registration/license number to “unique facility identifier”

  • Anticoagulant no longer has to precede proper name


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Revisions to Labeling and Storage Blood Components, Including Source Plasma

  • SP storage temp changed from –20 C to –30 C

  • SP shipping temp changed to –15C

  • FFP/Cryo

    • Storage temp

      • -18 to -25 3 month expiration

      • -25 or colder 2 year expiration

    • Shipping temp

      • Same as storage


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Revisions to Labeling and Storage Blood Components, Including Source Plasma

  • Comments due by 10/28/03

  • Sent to:

    • Division of Dockets Management (HFA-305)

    • FDA

    • 5630 Fishers Lane, Rm 1061

    • Rockville, MD 20852

    • Or

    • www.fda.gov/dockets/ecomments

    • Docket No. 2003N-0211


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Revisions to Labeling and Storage Blood Components, Including Source Plasma

  • Changed testing statement to include all required testing not just HIV, HBV and Syphilis

  • Testing statement on recovered plasma

  • Du to weak D


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