Home/CFR/Title 21/Part 640
FEDERAL · 21 CFR

Part 640 — Additional Standards for Human Blood and Blood Products

61 sections · Title 21: Food and Drugs

§ 640.1Whole Blood.
§ 640.2General requirements.
§ 640.4Collection of the blood.
§ 640.5Testing the blood.
§ 640.6Modifications of Whole Blood.
§ 640.10Red Blood Cells.
§ 640.11General requirements.
§ 640.12Eligibility of donor.
§ 640.13Collection of the blood.
§ 640.14Testing the blood.
§ 640.15Segments for testing.
§ 640.16Processing.
§ 640.17Modifications for specific products.
§ 640.20Platelets.
§ 640.21Eligibility of donors.
§ 640.22Collection of source material.
§ 640.23Testing the blood.
§ 640.24Processing.
§ 640.25General requirements.
§ 640.30Plasma.
§ 640.31Eligibility of donors.
§ 640.32Collection of source material.
§ 640.33Testing the blood.
§ 640.34Processing.
§ 640.50Cryoprecipitated AHF.
§ 640.51Eligibility of donors.
§ 640.52Collection of source material.
§ 640.53Testing the blood.
§ 640.54Processing.
§ 640.55U.S. Standard preparation.
§ 640.56Quality control test for potency.
§ 640.60Source Plasma.
§ 640.64Collection of blood for Source Plasma.
§ 640.65Plasmapheresis.
§ 640.66Immunization of donors.
§ 640.67Laboratory tests.
§ 640.68Processing.
§ 640.69General requirements.
§ 640.71Manufacturing responsibility.
§ 640.72Records.
§ 640.73Reporting of fatal donor reactions.
§ 640.74Modification of Source Plasma.
§ 640.76Products stored or shipped at unacceptable temperatures.
§ 640.80Albumin (Human).
§ 640.81Processing.
§ 640.82Tests on final product.
§ 640.83General requirements.
§ 640.84Labeling.
§ 640.90Plasma Protein Fraction (Human).
§ 640.91Processing.
§ 640.92Tests on final product.
§ 640.93General requirements.
§ 640.94Labeling.
§ 640.100Immune Globulin (Human).
§ 640.101General requirements.
§ 640.102Manufacture of Immune Globulin (Human).
§ 640.103The final product.
§ 640.104Potency.
§ 640.120Alternative procedures.
§ 640.125Definitions.
§ 640.130Medical supervision.