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.

FEDERAL REGISTER: Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback" - 6/24/2008

FEDERAL REGISTER: Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment; Direct Final Rule - 2/8/2008

FEDERAL REGISTER: Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Direct Final Rule; Correction - 9/24/2007

FEDERAL REGISTER: Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Direct Final Rule - 8/15/2007

FEDERAL REGISTER: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Extension of Comment Period; Proposed Rule - 1/11/2008

FEDERAL REGISTER: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Proposed Rule - 11/8/2007

FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule - 11/30/2007

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

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 Hepatitis C Virus Infection ("Lookback"); Final Rule - 8/24/2007

FEDERAL REGISTER: Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay; Final Rule - 8/8/2007

Federal Register: Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Delay of Applicability Date; Final Rule; Delay of Applicability Date - 11/13/2006

FEDERAL REGISTER Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures; Proposed Rule - 2/1/2006 - (PDF), (Text)

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 New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule - 5/31/2002 (Animal Rule)

Animal Models — Essential Elements to Address Efficacy Under the Animal Rule - 9/2008

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 Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule - 11/7/2000 - (PDF), (Text)

Biological Product Deviation Reporting - Form, Instructions, Codes
FEDERAL REGISTER Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule
CORRECTION: Effective date is May 7, 2001 - 11/9/2000 - (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)