Code of Federal Regulations (Last Updated: October 10, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter F - Biologics |
Part 640 - Additional Standards for Human Blood and Blood Products |
Subpart A - Whole Blood |
§ 640.1 - Whole Blood. |
§ 640.2 - General requirements. |
§ 640.3 - Suitability of donor. |
§ 640.4 - Collection of the blood. |
§ 640.5 - Testing the blood. |
§ 640.6 - Modifications of Whole Blood. |
Subpart B - Red Blood Cells |
§ 640.10 - Red Blood Cells. |
§ 640.11 - General requirements. |
§ 640.12 - Eligibility of donor. |
§ 640.13 - Collection of the blood. |
§ 640.14 - Testing the blood. |
§ 640.15 - Segments for testing. |
§ 640.16 - Processing. |
§ 640.17 - Modifications for specific products. |
Subpart C - Platelets |
§ 640.20 - Platelets. |
§ 640.21 - Eligibility of donors. |
§ 640.22 - Collection of source material. |
§ 640.23 - Testing the blood. |
§ 640.24 - Processing. |
§ 640.25 - General requirements. |
§ 640.27 - Emergency provisions. |
Subpart D - Plasma |
§ 640.30 - Plasma. |
§ 640.31 - Eligibility of donors. |
§ 640.32 - Collection of source material. |
§ 640.33 - Testing the blood. |
§ 640.34 - Processing. |
Subpart E - XXX |
Subpart F - Cryoprecipitate |
§ 640.50 - Cryoprecipitated AHF. |
§ 640.51 - Eligibility of donors. |
§ 640.52 - Collection of source material. |
§ 640.53 - Testing the blood. |
§ 640.54 - Processing. |
§ 640.55 - U.S. Standard preparation. |
§ 640.56 - Quality control test for potency. |
Subpart G - Source Plasma |
§ 640.60 - Source Plasma. |
§ 640.61 - Informed consent. |
§ 640.62 - Medical supervision. |
§ 640.63 - Suitability of donor. |
§ 640.64 - Collection of blood for Source Plasma. |
§ 640.65 - Plasmapheresis. |
§ 640.66 - Immunization of donors. |
§ 640.67 - Laboratory tests. |
§ 640.68 - Processing. |
§ 640.69 - General requirements. |
§ 640.70 - Labeling. |
§ 640.71 - Manufacturing responsibility. |
§ 640.72 - Records. |
§ 640.73 - Reporting of fatal donor reactions. |
§ 640.74 - Modification of Source Plasma. |
§ 640.76 - Products stored or shipped at unacceptable temperatures. |
Subpart H - Albumin (Human) |
§ 640.80 - Albumin (Human). |
§ 640.81 - Processing. |
§ 640.82 - Tests on final product. |
§ 640.83 - General requirements. |
§ 640.84 - Labeling. |
Subpart I - Plasma Protein Fraction (Human) |
§ 640.90 - Plasma Protein Fraction (Human). |
§ 640.91 - Processing. |
§ 640.92 - Tests on final product. |
§ 640.93 - General requirements. |
§ 640.94 - Labeling. |
Subpart J - Immune Globulin (Human) |
§ 640.100 - Immune Globulin (Human). |
§ 640.101 - General requirements. |
§ 640.102 - Manufacture of Immune Globulin (Human). |
§ 640.103 - The final product. |
§ 640.104 - Potency. |
Subpart K - XXX |
Subpart L - Alternative Procedures |
§ 640.120 - Alternative procedures. |
Subpart M - Definitions and Medical Supervision |
§ 640.125 - Definitions. |
§ 640.130 - Medical supervision. |