21 C.F.R. PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS


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

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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.
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Subpart B--RED BLOOD CELLS

�640.10
Red Blood Cells.
�640.11
General requirements.
�640.12
Suitability 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.
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Subpart C--PLATELETS

�640.20
Platelets.
�640.21
Suitability of donors.
�640.22
Collection of source material.
�640.23
Testing the blood.
�640.24
Processing.
�640.25
General requirements.
�640.27
Emergency provisions.
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Subpart D--PLASMA

�640.30
Plasma.
�640.31
Suitability of donors.
�640.32
Collection of source material.
�640.33
Testing the blood.
�640.34
Processing.
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Subpart E--[RESERVED]

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Subpart F--CRYOPRECIPITATE

�640.50
Cryoprecipitated AHF.
�640.51
Suitability 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.
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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.
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Subpart H--ALBUMIN (HUMAN)

�640.80
Albumin (Human).
�640.81
Processing.
�640.82
Tests on final product.
�640.83
General requirements.
�640.84
Labeling.
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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.
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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.
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Subpart K--[RESERVED]

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Subpart L--ALTERNATIVE PROCEDURES

�640.120
Alternative procedures.
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