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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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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. |