{"abstract":"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.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2012/01/03/2011-33554.html","cfr_references":[{"chapter":null,"citation_url":null,"part":606,"title":21},{"chapter":null,"citation_url":null,"part":610,"title":21},{"chapter":null,"citation_url":null,"part":640,"title":21}],"citation":"77 FR 7","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective July 2, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2003-N-0097"],"dockets":[],"document_number":"2011-33554","effective_on":"2012-07-02","end_page":18,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/01/03/2011-33554.xml","html_url":"https://www.federalregister.gov/documents/2012/01/03/2011-33554/revisions-to-labeling-requirements-for-blood-and-blood-components-including-source-plasma","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-33554?publication_date=2012-01-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-01-03/2011-33554/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":3757,"last_updated":"2026-09-22 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-01-03/pdf/2011-33554.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2011-33554.pdf?1325253002","publication_date":"2012-01-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/01/03/2011-33554.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 2 Farrugia and Prowse Studies on the procurement of blood coagulation factor VIII: effects of plasma freezing rate and storage conditions on cryoprecipitate quality. J Clin Pathol 1985; 38:433-437 re: Comment from \nEuropean Pharmacopoeia (PhEur)","document_id":"FDA-2003-N-0097-0032"},{"title":"Attachment 1 Åkerblom et al Freezing technique and quality of fresh-frozen plasma. Infusionstherapie 1992; 19:283-287 re: Comment from European Pharmacopoeia (PhEur)","document_id":"FDA-2003-N-0097-0031"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2003-N-0097","supporting_documents_count":2,"docket_id":"FDA-2003-N-0097","regulation_id_number":null,"title":"Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma","checked_regulationsdotgov_at":"2012-02-26T19:27:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7,"subtype":null,"title":"Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma","toc_doc":"Labeling Requirements for Blood and Blood Components, Including Source Plasma; Revisions","toc_subject":null,"topics":["Biologics","Blood","Labeling","Laboratories","Reporting and recordkeeping requirements"],"type":"Rule","volume":77}