21 CFR 640.100 - Immune Globulin (Human).

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§ 640.100 Immune Globulin (Human).
(a) Proper name and definition. The proper name of this product shall be Immune Globulin (Human). The product is defined as a sterile solution containing antibodies derived from human plasma.
(b) Source material. The source material of Immune Globulin (Human) shall be plasma recovered from Whole Blood prepared as prescribed in §§ 640.1 through 640.5, or Source Plasma prepared as prescribed in §§ 640.60 through 640.76.
(c) Additives in source material. The source material shall contain no additives other than citrate or acid citrate dextrose anticoagulant solution, unless it is shown that the processing method yields a product free of the additive to such an extent that the safety, purity, and potency of the product will not be affected adversely.
[38 FR 32089, Nov. 20, 1973, as amended at 50 FR 4140, Jan. 29, 1985; 64 FR 26287, May 14, 1999]

Title 21 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-05-22; vol. 80 # 99 - Friday, May 22, 2015
    1. 80 FR 29842 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 23, 2016.
      21 CFR Parts 606, 610, 630, 640, 660, and 820

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 640 after this date.

  • 2015-05-22; vol. 80 # 99 - Friday, May 22, 2015
    1. 80 FR 29842 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 23, 2016.
      21 CFR Parts 606, 610, 630, 640, 660, and 820