21 CFR
Part 640 Additional Standards for Human Blood and Blood Products
Subpart A - Whole Blood
- § 640.1 Whole Blood
- § 640.2 General requirements 5 × 483
- § 640.4 Collection of the blood 59 × 483
- § 640.5 Testing the blood 4 × 483
- § 640.6 Modifications of Whole Blood
Subpart B - Red Blood Cells
- § 640.10 Red Blood Cells
- § 640.11 General requirements 16 × 483
- § 640.12 Eligibility of donor
- § 640.13 Collection of the blood
- § 640.14 Testing the blood
- § 640.15 Segments for testing 1 × 483
- § 640.16 Processing 1 × 483
- § 640.17 Modifications for specific products
Subpart C - Platelets
- § 640.20 Platelets
- § 640.21 Eligibility of donors 19 × 483
- § 640.22 Collection of source material
- § 640.23 Testing the blood
- § 640.24 Processing 1 × 483
- § 640.25 General requirements 49 × 483
Subpart D - Plasma
- § 640.30 Plasma
- § 640.31 Eligibility of donors 18 × 483
- § 640.32 Collection of source material
- § 640.33 Testing the blood
- § 640.34 Processing 6 × 483
Subpart F - Cryoprecipitate
- § 640.50 Cryoprecipitated AHF
- § 640.51 Eligibility of donors
- § 640.52 Collection of source material 1 × 483
- § 640.53 Testing the blood
- § 640.54 Processing
- § 640.55 U.S. Standard preparation
- § 640.56 Quality control test for potency 1 × 483
Subpart G - Source Plasma
- § 640.60 Source Plasma
- § 640.64 Collection of blood for Source Plasma 26 × 483
- § 640.65 Plasmapheresis 20 × 483
- § 640.66 Immunization of donors 2 × 483
- § 640.67 Laboratory tests 2 × 483
- § 640.68 Processing 4 × 483
- § 640.69 General requirements 1 × 483
- § 640.71 Manufacturing responsibility
- § 640.72 Records 11 × 483
- § 640.73 Reporting of fatal donor reactions 1 × 483
- § 640.74 Modification of Source Plasma
- § 640.76 Products stored or shipped at unacceptable temperatures 5 × 483
Subpart H - Albumin (Human)
- § 640.80 Albumin (Human)
- § 640.81 Processing 1 × 483
- § 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 L - Alternative Procedures
- § 640.120 Alternative procedures 5 × 483