Part 640 — Additional Standards for Human Blood and Blood Products
Current through Sep 8, 2026
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.
Sections
- § 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.
- § 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.
- § 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.
- § 640.30 Plasma.
- § 640.31 Eligibility of donors.
- § 640.32 Collection of source material.
- § 640.33 Testing the blood.
- § 640.34 Processing.
- § 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.
- § 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.
- § 640.80 Albumin (Human).
- § 640.81 Processing.
- § 640.82 Tests on final product.
- § 640.83 General requirements.
- § 640.84 Labeling.
- § 640.90 Plasma Protein Fraction (Human).
- § 640.91 Processing.
- § 640.92 Tests on final product.
- § 640.93 General requirements.
- § 640.94 Labeling.
- § 640.100 Immune Globulin (Human).
- § 640.101 General requirements.
- § 640.102 Manufacture of Immune Globulin (Human).
- § 640.103 The final product.
- § 640.104 Potency.
- § 640.120 Alternative procedures.
- § 640.125 Definitions.
- § 640.130 Medical supervision.