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

Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma. December 12, 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

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  1. Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma December 12, 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 regulations for container labels and instruction circular • Remove inconsistencies with ISBT 128 • Modify shipping and storage temperatures for frozen no cellular products

  3. Revisions to Labeling and Storage • Combined both WB and SP labeling requirements into one section of the CFR • Registration/license number to “unique facility identifier” • Anticoagulant no longer has to precede proper name • Changed testing statement to include all required testing not just HIV, HBV and Syphilis

  4. Revisions to Labeling and Storage • SP storage temp changed from –20o C to –30o C • SP shipping temp changed from –5o C to –15o C • FFP/Cryo • Storage temp • -18o C to –25o C 3 month expiration • -25o C or colder 2 year expiration • Shipping temp • Same as storage

  5. Revisions to Labeling and Storage • Comments were due by 10/28/03 • To date we have received 17 comments • Most have to do with temp changes • Freezer alarms preset • Cost of new equipment • Lack of data to support proposed changes • Worker safety issues in regard to lower temps • Keeping 2 inventories of FFP

  6. Revisions to Labeling and Storage • To address these issues FDA is planning a public meeting • To be held • February 27, 2004 • Lister Hill Auditorium • Times and agenda to be announced

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