Title 21

PART 640

Part 640 - Additional Standards For Human Blood And Blood Products

PART 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS 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. Cross References:

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.

21:7.0.1.1.7.1SUBPART A
Subpart A - Whole Blood
21:7.0.1.1.7.1.1.1SECTION 640.1
   640.1 Whole Blood.
21:7.0.1.1.7.1.1.2SECTION 640.2
   640.2 General requirements.
21:7.0.1.1.7.1.1.3SECTION 640.4
   640.4 Collection of the blood.
21:7.0.1.1.7.1.1.4SECTION 640.5
   640.5 Testing the blood.
21:7.0.1.1.7.1.1.5SECTION 640.6
   640.6 Modifications of Whole Blood.
21:7.0.1.1.7.2SUBPART B
Subpart B - Red Blood Cells
21:7.0.1.1.7.2.1.1SECTION 640.10
   640.10 Red Blood Cells.
21:7.0.1.1.7.2.1.2SECTION 640.11
   640.11 General requirements.
21:7.0.1.1.7.2.1.3SECTION 640.12
   640.12 Eligibility of donor.
21:7.0.1.1.7.2.1.4SECTION 640.13
   640.13 Collection of the blood.
21:7.0.1.1.7.2.1.5SECTION 640.14
   640.14 Testing the blood.
21:7.0.1.1.7.2.1.6SECTION 640.15
   640.15 Segments for testing.
21:7.0.1.1.7.2.1.7SECTION 640.16
   640.16 Processing.
21:7.0.1.1.7.2.1.8SECTION 640.17
   640.17 Modifications for specific products.
21:7.0.1.1.7.3SUBPART C
Subpart C - Platelets
21:7.0.1.1.7.3.1.1SECTION 640.20
   640.20 Platelets.
21:7.0.1.1.7.3.1.2SECTION 640.21
   640.21 Eligibility of donors.
21:7.0.1.1.7.3.1.3SECTION 640.22
   640.22 Collection of source material.
21:7.0.1.1.7.3.1.4SECTION 640.23
   640.23 Testing the blood.
21:7.0.1.1.7.3.1.5SECTION 640.24
   640.24 Processing.
21:7.0.1.1.7.3.1.6SECTION 640.25
   640.25 General requirements.
21:7.0.1.1.7.4SUBPART D
Subpart D - Plasma
21:7.0.1.1.7.4.1.1SECTION 640.30
   640.30 Plasma.
21:7.0.1.1.7.4.1.2SECTION 640.31
   640.31 Eligibility of donors.
21:7.0.1.1.7.4.1.3SECTION 640.32
   640.32 Collection of source material.
21:7.0.1.1.7.4.1.4SECTION 640.33
   640.33 Testing the blood.
21:7.0.1.1.7.4.1.5SECTION 640.34
   640.34 Processing.
21:7.0.1.1.7.5SUBPART E
Subpart E [Reserved]
21:7.0.1.1.7.6SUBPART F
Subpart F - Cryoprecipitate
21:7.0.1.1.7.6.1.1SECTION 640.50
   640.50 Cryoprecipitated AHF.
21:7.0.1.1.7.6.1.2SECTION 640.51
   640.51 Eligibility of donors.
21:7.0.1.1.7.6.1.3SECTION 640.52
   640.52 Collection of source material.
21:7.0.1.1.7.6.1.4SECTION 640.53
   640.53 Testing the blood.
21:7.0.1.1.7.6.1.5SECTION 640.54
   640.54 Processing.
21:7.0.1.1.7.6.1.6SECTION 640.55
   640.55 U.S. Standard preparation.
21:7.0.1.1.7.6.1.7SECTION 640.56
   640.56 Quality control test for potency.
21:7.0.1.1.7.7SUBPART G
Subpart G - Source Plasma
21:7.0.1.1.7.7.1.1SECTION 640.60
   640.60 Source Plasma.
21:7.0.1.1.7.7.1.2SECTION 640.64
   640.64 Collection of blood for Source Plasma.
21:7.0.1.1.7.7.1.3SECTION 640.65
   640.65 Plasmapheresis.
21:7.0.1.1.7.7.1.4SECTION 640.66
   640.66 Immunization of donors.
21:7.0.1.1.7.7.1.5SECTION 640.67
   640.67 Laboratory tests.
21:7.0.1.1.7.7.1.6SECTION 640.68
   640.68 Processing.
21:7.0.1.1.7.7.1.7SECTION 640.69
   640.69 General requirements.
21:7.0.1.1.7.7.1.8SECTION 640.71
   640.71 Manufacturing responsibility.
21:7.0.1.1.7.7.1.9SECTION 640.72
   640.72 Records.
21:7.0.1.1.7.7.1.10SECTION 640.73
   640.73 Reporting of fatal donor reactions.
21:7.0.1.1.7.7.1.11SECTION 640.74
   640.74 Modification of Source Plasma.
21:7.0.1.1.7.7.1.12SECTION 640.76
   640.76 Products stored or shipped at unacceptable temperatures.
21:7.0.1.1.7.8SUBPART H
Subpart H - Albumin (Human)
21:7.0.1.1.7.8.1.1SECTION 640.80
   640.80 Albumin (Human).
21:7.0.1.1.7.8.1.2SECTION 640.81
   640.81 Processing.
21:7.0.1.1.7.8.1.3SECTION 640.82
   640.82 Tests on final product.
21:7.0.1.1.7.8.1.4SECTION 640.83
   640.83 General requirements.
21:7.0.1.1.7.8.1.5SECTION 640.84
   640.84 Labeling.
21:7.0.1.1.7.9SUBPART I
Subpart I - Plasma Protein Fraction (Human)
21:7.0.1.1.7.9.1.1SECTION 640.90
   640.90 Plasma Protein Fraction (Human).
21:7.0.1.1.7.9.1.2SECTION 640.91
   640.91 Processing.
21:7.0.1.1.7.9.1.3SECTION 640.92
   640.92 Tests on final product.
21:7.0.1.1.7.9.1.4SECTION 640.93
   640.93 General requirements.
21:7.0.1.1.7.9.1.5SECTION 640.94
   640.94 Labeling.
21:7.0.1.1.7.10SUBPART J
Subpart J - Immune Globulin (Human)
21:7.0.1.1.7.10.1.1SECTION 640.100
   640.100 Immune Globulin (Human).
21:7.0.1.1.7.10.1.2SECTION 640.101
   640.101 General requirements.
21:7.0.1.1.7.10.1.3SECTION 640.102
   640.102 Manufacture of Immune Globulin (Human).
21:7.0.1.1.7.10.1.4SECTION 640.103
   640.103 The final product.
21:7.0.1.1.7.10.1.5SECTION 640.104
   640.104 Potency.
21:7.0.1.1.7.11SUBPART K
Subpart K [Reserved]
21:7.0.1.1.7.12SUBPART L
Subpart L - Alternative Procedures
21:7.0.1.1.7.12.1.1SECTION 640.120
   640.120 Alternative procedures.
21:7.0.1.1.7.13SUBPART M
Subpart M - Definitions and Medical Supervision
21:7.0.1.1.7.13.1.1SECTION 640.125
   640.125 Definitions.
21:7.0.1.1.7.13.1.2SECTION 640.130
   640.130 Medical supervision.