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 - 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.
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.
§ 640.27 - Emergency provisions.
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.
Subpart E - XXX
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.
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 - XXX
Subpart L - Alternative Procedures
§ 640.120 - Alternative procedures.
Subpart M - Definitions and Medical Supervision
§ 640.125 - Definitions.
§ 640.130 - Medical supervision.