21 C.F.R. § 640.32 Collection of source material.
Title 21 - Food and Drugs
(a) Whole blood shall be collected, transported, and stored as prescribed in §640.4. When whole blood is intended for Plasma, Fresh Frozen Plasma, and Liquid Plasma, it shall be maintained at a temperature between 1 and 6 °C until the plasma is removed. Whole blood intended for Platelet Rich Plasma, shall be maintained as prescribed in §640.24 until the plasma is removed. The red blood cells shall be placed in storage at a temperature between 1 and 6 °C immediately after the plasma is separated. (b) Plasma obtained by plasmapheresis shall be collected as prescribed in §§640.62, 640.64 (except that paragraph (c)(3) of §640.64 shall not apply), and §640.65. [42 FR 59878, Nov. 22, 1977, as amended at 45 FR 27927, Apr. 25, 1980; 50 FR 4139, Jan. 29, 1985; 64 FR 45372, Aug. 19, 1999]
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart D—Plasma
§ 640.32 Collection of source material.
