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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

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.

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.

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.

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.

Subpart E--[RESERVED]

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.

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.

Subpart H--ALBUMIN (HUMAN)

�640.80

Albumin (Human).

�640.81

Processing.

�640.82

Tests on final product.

�640.83

General requirements.

�640.84

Labeling.

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.

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.

Subpart K--[RESERVED]

Subpart L--ALTERNATIVE PROCEDURES

�640.120

Alternative procedures.