StacksVerified U.S. regulatory reference

21 CFR §640.55

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
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 of this chapter) for use in the preparation of a working reference to be employed in a quality control potency test of Cryoprecipitated AHF.