21 CFR Part 640
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
- PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter F—Biologics
- Subpart A—Whole Blood
- § 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.
- 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.
- 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 [Reserved]
- 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.
- § 640.64 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.
- 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.
- Subpart M—Definitions and Medical Supervision
- § 640.125 Definitions.
- § 640.130 Medical supervision.
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