CFR section

21 CFR 640.4(h): Collection of the blood

PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart A-Whole Blood

Key facts

Citation 21 CFR 640.4(h)
Section Collection of the blood
Part PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart Subpart A-Whole Blood
Subchapter 21 CFR F Biologics
Product types cited Biologics, Drugs
Regulation text (excerpt) (h) Storage. Whole Blood must be placed in storage at a temperature between 1 and 6 °C immediately after collection unless the blood is to be further processed into another component or the blood must be transported from the donor center to the processing laboratory. If transported, the blood must be placed in temporary storage having sufficient refrigeration capacity to cool the blood continuously toward a temperature range between 1 and 10 °C until arrival at the processing laboratory. At the…

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