Blood Proposed and Final Rules
The rules on this page are arranged in order by date, with the most recent rule added to the top of the list.
Blood Publications
FEDERAL REGISTER Bar Code Label Requirement for Human Drug Products and Biological Products; Final Rule; Correction - 4/7/2004 -
(PDF),
(Text)
- FEDERAL REGISTER Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule - 2/26/2004 -
(PDF),
(Text)
FEDERAL REGISTER Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma; Correction - Proposed Rule; correction - 10/27/2003 -
(PDF),
(Text)
- FEDERAL REGISTER Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma - Proposed Rule - 7/30/2003 -
(PDF),
(Text)
FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices;
Reclassification of Automated Blood Cell Separator Device Operating by
Filtration Principle from Class III to Class II; Final rule - 2/28/2003 -
(PDF),
(Text)
FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Final Rule - 8/6/2001 -
(PDF),
(Text)
FEDERAL REGISTER Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents - 6/11/2001 -
(PDF),
(Text)
FEDERAL REGISTER General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification - 6/11/2001 -
(PDF),
(Text)
FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Confirmation in Part and Technical Amendment - 1/10/2001
(PDF),
(Text)
FEDERAL REGISTER Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Final Rule - 12/12/2000 -
(PDF),
(Text)
FEDERAL REGISTER Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Companion to Direct Final Rule - 12/12/2000 -
(PDF),
(Text)
FEDERAL REGISTER Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection ("Lookback"); Proposed Rule - 11/16/2000 -
(PDF),
(Text)
FEDERAL REGISTER Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule - 11/7/2000 -
(PDF),
(Text)
FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin (Human); Final Rule - 8/28/2000 -
(PDF),
(Text)
FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Confirmation in Part and Technical Amendment; Final Rule - 3/14/2000 -
(PDF),
(Text)
FEDERAL REGISTER Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; Proposed Rule - 8/19/99 -
(PDF),
(Text)
FEDERAL REGISTER General Requirements for Blood, Blood Components and Blood Derivatives; Notification of Deferred Donors; Proposed Rule - 8/19/99 -
(PDF),
(Text)
FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Direct Final Rule - 8/19/99 -
(PDF),
(Text)
FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Companion Document to Direct Final Rule; Proposed Rule - 8/19/99 -
(PDF),
(Text)
FEDERAL REGISTER Plasma Derivatives and Other Blood-Derived Products; Requirements for Tracking and Notification; Advance Notice of Proposed Rulemaking - 8/19/99 -
(PDF),
(Text)
FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Direct Final Rule - 5/14/99 -
(PDF),
(Text)
FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Companion Document to Direct Final Rule; Proposed Rule - 5/14/99 -
(PDF),
(Text)
FEDERAL REGISTER Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule - 9/23/97; Correction 11/3/97 -
(PDF),
(Text)
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