---
kind: "section"
citation: "21 C.F.R. § 640.55"
title: "21"
number: "640.55"
heading: "U.S. Standard preparation."
url: "https://uscodex.org/cfr/21/640.55"
---

# §640.55. U.S. Standard preparation.


A U.S. Standard Antihemophilic Factor (Factor VIII) preparation may be obtained from the Center for Biologics Evaluation and Research, (HFM-407) (see mailing addresses in [§ 600.2](/cfr/21/600.2.md) of this chapter) for use in the preparation of a working reference to be employed in a quality control potency test of Cryoprecipitated AHF.


## Notes

### Amendments

[42 FR 21774, Apr. 29, 1977, as amended at 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 70 FR 14985, Mar. 24, 2005]

### 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 21774, Apr. 29, 1977, as amended at 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 70 FR 14985, Mar. 24, 2005]