---
kind: "section"
citation: "21 C.F.R. § 640.100"
title: "21"
number: "640.100"
heading: "Immune Globulin (Human)."
url: "https://uscodex.org/cfr/21/640.100"
---

# §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](/cfr/21/640.1..640.5.md), or Source Plasma prepared as prescribed in [§§ 640.60 through 640.76](/cfr/21/640.60..640.76.md).
- (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.

## Notes

### Amendments

[38 FR 32089, Nov. 20, 1973, as amended at 50 FR 4140, Jan. 29, 1985; 64 FR 26287, May 14, 1999]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

### Source

Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

### Amendments

[38 FR 32089, Nov. 20, 1973, as amended at 50 FR 4140, Jan. 29, 1985; 64 FR 26287, May 14, 1999]