---
kind: "section"
citation: "21 C.F.R. § 640.90"
title: "21"
number: "640.90"
heading: "Plasma Protein Fraction (Human)."
url: "https://uscodex.org/cfr/21/640.90"
---

# §640.90. Plasma Protein Fraction (Human).

- (a) **Proper name and definition.** The proper name of the product shall be Plasma Protein Fraction (Human). The product is defined as a sterile solution of protein composed of albumin and globulin, derived from human plasma.
- (b) **Source material.** The source material of Plasma Protein Fraction (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.** Source material shall not contain an additive unless it is shown that the processing method yields a final product free of the additive to such extent that the continued safety, purity, potency, and effectiveness of the final product will not be adversely affected.

## Notes

### Amendments

[42 FR 27583, May 31, 1977, as amended at 64 FR 26286, May 14, 1999]

### Source

Source: 42 FR 27583, May 31, 1977, unless otherwise noted.

### 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

[42 FR 27583, May 31, 1977, as amended at 64 FR 26286, May 14, 1999]