Title 21
PART 640
Part 640 - Additional Standards For Human Blood And Blood Products
For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23. For U.S. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111.
- Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.
- Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.
| 21:7.0.1.1.7.1 | SUBPART A | Subpart A - Whole Blood | |
| 21:7.0.1.1.7.1.1.1 | SECTION 640.1 | 640.1 Whole Blood. | |
| 21:7.0.1.1.7.1.1.2 | SECTION 640.2 | 640.2 General requirements. | |
| 21:7.0.1.1.7.1.1.3 | SECTION 640.4 | 640.4 Collection of the blood. | |
| 21:7.0.1.1.7.1.1.4 | SECTION 640.5 | 640.5 Testing the blood. | |
| 21:7.0.1.1.7.1.1.5 | SECTION 640.6 | 640.6 Modifications of Whole Blood. | |
| 21:7.0.1.1.7.2 | SUBPART B | Subpart B - Red Blood Cells | |
| 21:7.0.1.1.7.2.1.1 | SECTION 640.10 | 640.10 Red Blood Cells. | |
| 21:7.0.1.1.7.2.1.2 | SECTION 640.11 | 640.11 General requirements. | |
| 21:7.0.1.1.7.2.1.3 | SECTION 640.12 | 640.12 Eligibility of donor. | |
| 21:7.0.1.1.7.2.1.4 | SECTION 640.13 | 640.13 Collection of the blood. | |
| 21:7.0.1.1.7.2.1.5 | SECTION 640.14 | 640.14 Testing the blood. | |
| 21:7.0.1.1.7.2.1.6 | SECTION 640.15 | 640.15 Segments for testing. | |
| 21:7.0.1.1.7.2.1.7 | SECTION 640.16 | 640.16 Processing. | |
| 21:7.0.1.1.7.2.1.8 | SECTION 640.17 | 640.17 Modifications for specific products. | |
| 21:7.0.1.1.7.3 | SUBPART C | Subpart C - Platelets | |
| 21:7.0.1.1.7.3.1.1 | SECTION 640.20 | 640.20 Platelets. | |
| 21:7.0.1.1.7.3.1.2 | SECTION 640.21 | 640.21 Eligibility of donors. | |
| 21:7.0.1.1.7.3.1.3 | SECTION 640.22 | 640.22 Collection of source material. | |
| 21:7.0.1.1.7.3.1.4 | SECTION 640.23 | 640.23 Testing the blood. | |
| 21:7.0.1.1.7.3.1.5 | SECTION 640.24 | 640.24 Processing. | |
| 21:7.0.1.1.7.3.1.6 | SECTION 640.25 | 640.25 General requirements. | |
| 21:7.0.1.1.7.4 | SUBPART D | Subpart D - Plasma | |
| 21:7.0.1.1.7.4.1.1 | SECTION 640.30 | 640.30 Plasma. | |
| 21:7.0.1.1.7.4.1.2 | SECTION 640.31 | 640.31 Eligibility of donors. | |
| 21:7.0.1.1.7.4.1.3 | SECTION 640.32 | 640.32 Collection of source material. | |
| 21:7.0.1.1.7.4.1.4 | SECTION 640.33 | 640.33 Testing the blood. | |
| 21:7.0.1.1.7.4.1.5 | SECTION 640.34 | 640.34 Processing. | |
| 21:7.0.1.1.7.5 | SUBPART E | Subpart E [Reserved] | |
| 21:7.0.1.1.7.6 | SUBPART F | Subpart F - Cryoprecipitate | |
| 21:7.0.1.1.7.6.1.1 | SECTION 640.50 | 640.50 Cryoprecipitated AHF. | |
| 21:7.0.1.1.7.6.1.2 | SECTION 640.51 | 640.51 Eligibility of donors. | |
| 21:7.0.1.1.7.6.1.3 | SECTION 640.52 | 640.52 Collection of source material. | |
| 21:7.0.1.1.7.6.1.4 | SECTION 640.53 | 640.53 Testing the blood. | |
| 21:7.0.1.1.7.6.1.5 | SECTION 640.54 | 640.54 Processing. | |
| 21:7.0.1.1.7.6.1.6 | SECTION 640.55 | 640.55 U.S. Standard preparation. | |
| 21:7.0.1.1.7.6.1.7 | SECTION 640.56 | 640.56 Quality control test for potency. | |
| 21:7.0.1.1.7.7 | SUBPART G | Subpart G - Source Plasma | |
| 21:7.0.1.1.7.7.1.1 | SECTION 640.60 | 640.60 Source Plasma. | |
| 21:7.0.1.1.7.7.1.2 | SECTION 640.64 | 640.64 Collection of blood for Source Plasma. | |
| 21:7.0.1.1.7.7.1.3 | SECTION 640.65 | 640.65 Plasmapheresis. | |
| 21:7.0.1.1.7.7.1.4 | SECTION 640.66 | 640.66 Immunization of donors. | |
| 21:7.0.1.1.7.7.1.5 | SECTION 640.67 | 640.67 Laboratory tests. | |
| 21:7.0.1.1.7.7.1.6 | SECTION 640.68 | 640.68 Processing. | |
| 21:7.0.1.1.7.7.1.7 | SECTION 640.69 | 640.69 General requirements. | |
| 21:7.0.1.1.7.7.1.8 | SECTION 640.71 | 640.71 Manufacturing responsibility. | |
| 21:7.0.1.1.7.7.1.9 | SECTION 640.72 | 640.72 Records. | |
| 21:7.0.1.1.7.7.1.10 | SECTION 640.73 | 640.73 Reporting of fatal donor reactions. | |
| 21:7.0.1.1.7.7.1.11 | SECTION 640.74 | 640.74 Modification of Source Plasma. | |
| 21:7.0.1.1.7.7.1.12 | SECTION 640.76 | 640.76 Products stored or shipped at unacceptable temperatures. | |
| 21:7.0.1.1.7.8 | SUBPART H | Subpart H - Albumin (Human) | |
| 21:7.0.1.1.7.8.1.1 | SECTION 640.80 | 640.80 Albumin (Human). | |
| 21:7.0.1.1.7.8.1.2 | SECTION 640.81 | 640.81 Processing. | |
| 21:7.0.1.1.7.8.1.3 | SECTION 640.82 | 640.82 Tests on final product. | |
| 21:7.0.1.1.7.8.1.4 | SECTION 640.83 | 640.83 General requirements. | |
| 21:7.0.1.1.7.8.1.5 | SECTION 640.84 | 640.84 Labeling. | |
| 21:7.0.1.1.7.9 | SUBPART I | Subpart I - Plasma Protein Fraction (Human) | |
| 21:7.0.1.1.7.9.1.1 | SECTION 640.90 | 640.90 Plasma Protein Fraction (Human). | |
| 21:7.0.1.1.7.9.1.2 | SECTION 640.91 | 640.91 Processing. | |
| 21:7.0.1.1.7.9.1.3 | SECTION 640.92 | 640.92 Tests on final product. | |
| 21:7.0.1.1.7.9.1.4 | SECTION 640.93 | 640.93 General requirements. | |
| 21:7.0.1.1.7.9.1.5 | SECTION 640.94 | 640.94 Labeling. | |
| 21:7.0.1.1.7.10 | SUBPART J | Subpart J - Immune Globulin (Human) | |
| 21:7.0.1.1.7.10.1.1 | SECTION 640.100 | 640.100 Immune Globulin (Human). | |
| 21:7.0.1.1.7.10.1.2 | SECTION 640.101 | 640.101 General requirements. | |
| 21:7.0.1.1.7.10.1.3 | SECTION 640.102 | 640.102 Manufacture of Immune Globulin (Human). | |
| 21:7.0.1.1.7.10.1.4 | SECTION 640.103 | 640.103 The final product. | |
| 21:7.0.1.1.7.10.1.5 | SECTION 640.104 | 640.104 Potency. | |
| 21:7.0.1.1.7.11 | SUBPART K | Subpart K [Reserved] | |
| 21:7.0.1.1.7.12 | SUBPART L | Subpart L - Alternative Procedures | |
| 21:7.0.1.1.7.12.1.1 | SECTION 640.120 | 640.120 Alternative procedures. | |
| 21:7.0.1.1.7.13 | SUBPART M | Subpart M - Definitions and Medical Supervision | |
| 21:7.0.1.1.7.13.1.1 | SECTION 640.125 | 640.125 Definitions. | |
| 21:7.0.1.1.7.13.1.2 | SECTION 640.130 | 640.130 Medical supervision. |