Electronic Code of Federal Regulations
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e-CFR data is current as of July 1, 2020 |
Title 21 → Chapter I → Subchapter F → Part 640 → Subpart F → §640.50 |
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart F—Cryoprecipitate
§640.50 Cryoprecipitated AHF.
(a) Proper name and definition. The proper name of this product shall be Cryoprecipitated AHF. The product is defined as a preparation of antihemophilic factor, which is obtained from a single unit of plasma collected and processed in a closed system.
(b) Source. The source material for Cryoprecipitated AHF shall be plasma which may be obtained by whole blood collection or by plasmapheresis.
[42 FR 21774, Apr. 29, 1977; 48 FR 13026, Mar. 29, 1983, as amended at 50 FR 4139, Jan. 29, 1985]