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Electronic Code of Federal Regulations

e-CFR data is current as of November 18, 2019

Title 21Chapter ISubchapter FPart 640


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

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.
§640.4
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
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.
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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.
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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.
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Subpart E—[RESERVED]

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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.
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Subpart G—SOURCE PLASMA

§640.60
Source Plasma.
§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.
§640.71
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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Subpart M—DEFINITIONS AND MEDICAL SUPERVISION

§640.125
Definitions.
§640.130
Medical supervision.

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