Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma - PowerPoint PPT Presentation

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

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  1. Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma September 18, 2003 Elizabeth Callaghan Division of Blood Applications

  2. Revisions to Labeling and Storage • 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

  3. Revisions to Labeling and Storage • 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

  4. Revisions to Labeling and Storage • 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

  5. Revisions to Labeling and Storage • 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

  6. Revisions to Labeling and Storage • Changed testing statement to include all required testing not just HIV, HBV and Syphilis • Testing statement on recovered plasma • Du to weak D