Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=640&amp;showFR=1&amp;subpartNode=21:7.0.1.1.7.4
Timestamp: 2019-04-25 19:55:06+00:00

Document:
§ 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.
§ 640.17 - Modifications for specific products.
§ 640.21 - Eligibility of donors.
§ 640.22 - Collection of source material.
§ 640.23 - Testing the blood.
§ 640.25 - General requirements.
§ 640.31 - Eligibility of donors.
§ 640.32 - Collection of source material.
§ 640.33 - Testing the blood.
§ 640.50 - Cryoprecipitated AHF.
§ 640.51 - Eligibility of donors.
§ 640.52 - Collection of source material.
§ 640.53 - Testing the blood.
§ 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.
§ 640.66 - Immunization of donors.
§ 640.67 - Laboratory tests.
§ 640.69 - General requirements.
§ 640.71 - Manufacturing responsibility.
§ 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).
§ 640.82 - Tests on final product.
§ 640.83 - General requirements.
§ 640.90 - Plasma Protein Fraction (Human).
§ 640.92 - Tests on final product.
§ 640.93 - General requirements.
§ 640.100 - Immune Globulin (Human).
§ 640.101 - General requirements.
§ 640.102 - Manufacture of Immune Globulin (Human).
§ 640.103 - The final product.
§ 640.120 - Alternative procedures.
§ 640.130 - Medical supervision.
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.

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