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[A1]

Electronic Code of Federal Regulations

e-CFR data is current as of July 9, 2020

Title 21 → Chapter I → Subchapter F → Part 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

rule

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.
rule

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.
rule

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.
rule

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.
rule

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.
rule

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.
rule

Subpart H—ALBUMIN (HUMAN)

§640.80
Albumin (Human).
§640.81
Processing.
§640.82
Tests on final product.
§640.83
General requirements.
§640.84
Labeling.
rule

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.
rule

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.
rule

Subpart K—[RESERVED]

rule

Subpart L—ALTERNATIVE PROCEDURES

§640.120
Alternative procedures.
rule

Subpart M—DEFINITIONS AND MEDICAL SUPERVISION

§640.125
Definitions.
§640.130
Medical supervision.

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