[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.1]

[Page 90-91]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
--Table of Contents
 
                          Subpart A_Whole Blood
 
Sec. 640.1  Whole Blood.




                          Subpart A_Whole Blood

Sec.
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 Cryoprecipitate 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.

[[Page 91]]

                         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.

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 
216, 262, 263, 263a, 264.

    Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

    Cross References: For U.S. Customs Service regulations relating to 
viruses, serums, and toxins, see 19 CFR 12.21-12.23. For U.S. Postal 
Service regulations relating to the admissibility to the United States 
mails see parts 124 and 125 of the Domestic Mail Manual, that is 
incorporated by reference in 39 CFR part 111.



    The proper name of this product shall be Whole Blood. Whole Blood is 
defined as blood collected from human donors for transfusion to human 
recipients.

[38 FR 32089, Nov. 20, 1973, as amended at 50 FR 4138, Jan. 29, 1985]