(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]
Notes of Decisions
Sykes v. Bayer Pharm. Corp., 548 F. Supp. 2d 208 (E.D. Va. 2008).
“Hy-pRho-D, which is manufactured by Bayer, is an immune globulin, a “sterile solution containing antibodies derived from human plasma,” 21 C.F.R. § 640.100 , that suppresses the immune response of a Rh-negative pregnant woman to Rh-positive blood cells from her fetus that enter…”
Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007).
“” 21 C.F.R. § 640.100 . 3 .The parties do not dispute that the products administered to Wesley were vaccines under the Vaccine Act.”
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