Title 21, Part 640 — Additional Standards for Human Blood and Blood Products
61 sections
Section 640.1
Whole Blood.
Section 640.2
General requirements.
Section 640.4
Collection of the blood.
Section 640.5
Testing the blood.
Section 640.6
Modifications of Whole Blood.
Section 640.10
Red Blood Cells.
Section 640.11
General requirements.
Section 640.12
Eligibility of donor.
Section 640.13
Collection of the blood.
Section 640.14
Testing the blood.
Section 640.15
Segments for testing.
Section 640.16
Processing.
Section 640.17
Modifications for specific products.
Section 640.20
Platelets.
Section 640.21
Eligibility of donors.
Section 640.22
Collection of source material.
Section 640.23
Testing the blood.
Section 640.24
Processing.
Section 640.25
General requirements.
Section 640.30
Plasma.
Section 640.31
Eligibility of donors.
Section 640.32
Collection of source material.
Section 640.33
Testing the blood.
Section 640.34
Processing.
Section 640.50
Cryoprecipitated AHF.
Section 640.51
Eligibility of donors.
Section 640.52
Collection of source material.
Section 640.53
Testing the blood.
Section 640.54
Processing.
Section 640.55
U.S. Standard preparation.
Section 640.56
Quality control test for potency.
Section 640.60
Source Plasma.
Section 640.64
Collection of blood for Source Plasma.
Section 640.65
Plasmapheresis.
Section 640.66
Immunization of donors.
Section 640.67
Laboratory tests.
Section 640.68
Processing.
Section 640.69
General requirements.
Section 640.71
Manufacturing responsibility.
Section 640.72
Records.
Section 640.73
Reporting of fatal donor reactions.
Section 640.74
Modification of Source Plasma.
Section 640.76
Products stored or shipped at unacceptable temperatures.
Section 640.80
Albumin (Human).
Section 640.81
Processing.
Section 640.82
Tests on final product.
Section 640.83
General requirements.
Section 640.84
Labeling.
Section 640.90
Plasma Protein Fraction (Human).
Section 640.91
Processing.
Section 640.92
Tests on final product.
Section 640.93
General requirements.
Section 640.94
Labeling.
Section 640.100
Immune Globulin (Human).
Section 640.101
General requirements.
Section 640.102
Manufacture of Immune Globulin (Human).
Section 640.103
The final product.
Section 640.104
Potency.
Section 640.120
Alternative procedures.
Section 640.125
Definitions.
Section 640.130
Medical supervision.