United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-01-03 article Rules and Regulations D09002ee1c7fe0820 D09002ee1c7fe0880 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the "ABC Codabar" system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling. 77 FR 7 https://www.govinfo.gov/app/details/FR-2012-01-03/2011-33554 2011-33554 fr03ja12-6 4160-01-P Docket No. FDA-2003-N-0097 https://www.govinfo.gov/app/details/FR-2012-01-03/2011-33554 https://www.govinfo.gov/content/pkg/FR-2012-01-03/html/2011-33554.htm https://www.govinfo.gov/content/pkg/FR-2012-01-03/pdf/2011-33554.pdf Blood Labeling Laboratories Reporting and Recordkeeping Requirements Biologics 12 p. 7 18 77 FR 7 Title 21 Part 606 21 CFR Part 606 Title 21 Part 610 21 CFR Part 610 Title 21 Part 640 21 CFR Part 640 Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma; Federal Register Vol. 77, Issue RULE 2011-33554 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-07-02 Docket No. FDA-2003-N-0097 4160-01-P 2011-33554 Final rule.

The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the "ABC Codabar" system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.

This rule is effective July 2, 2012. Benjamin Chacko, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, (301) 827-6210. Blood Labeling Laboratories Reporting and Recordkeeping Requirements Biologics Labeling Requirements for Blood and Blood Components, Including Source Plasma; Revisions , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm079004.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM079159.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM080974.pdf http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073876.htm Vol. 77, no. 1 Office of the Federal Register, National Archives and Records Administration 2012-01-03 continuing daily deposited born digital 222 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-01-03 P0b002ee1816be658 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr03ja12 https://www.govinfo.gov/app/details/FR-2012-01-03 https://www.govinfo.gov/content/pkg/FR-2012-01-03/pdf/FR-2012-01-03.pdf https://www.govinfo.gov/content/pkg/FR-2012-01-03/xml/FR-2012-01-03.xml fdlp 1 212 DGPO 2012-01-03 2024-06-03 FR-2012-01-03 machine generated eng FR FR-2012-01-03 77 1