21 C.F.R. Subpart D—Plasma
Title 21 - Food and Drugs
(a) Proper name and definition. The proper name of this product shall be Plasma. The product is defined as the fluid portion of one unit of human blood intended for intravenous use which in a closed system, has been collected, stabilized against clotting, and separated from the red blood cells. (b) Source. (1) Plasma shall be obtained by separating plasma from blood collected from blood donors or by plasmapheresis. (2) Plasma may be obtained from a unit of Whole Blood collected by another licensed establishment. [42 FR 59878, Nov. 22, 1977; 48 FR 13026, Mar. 29, 1983, as amended at 50 FR 4139, Jan. 29, 1985] (a) Whole blood donors shall meet the criteria for donor suitability prescribed in §640.3. (b) Plasmapheresis donors shall meet the criteria for donor suitability prescribed in §640.63, excluding the phrase “other than malaria” in paragraph (c)(9) of that section. Informed consent shall be required as prescribed in §640.61. [42 FR 59878, Nov. 22, 1977, as amended at 64 FR 45372, Aug. 19, 1999] (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] (a) Blood from which plasma is separated shall be tested as prescribed in §610.40 of this chapter and §640.5 (a), (b), and (c). (b) Manufacturers of Plasma collected by plasmapheresis shall have testing and recordkeeping responsibilities equivalent to those prescribed in §§640.71 and 640.72. [42 FR 59878, Nov. 22, 1977, as amended at 44 FR 17658, Mar. 23, 1979; 50 FR 4139, Jan. 29, 1985; 53 FR 117, Jan. 5, 1988; 66 FR 31165, June 11, 2001] (a) Plasma. Plasma shall be separated from the red blood cells and shall be stored at -18 °C or colder within 6 hours after transfer to the final container or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system unless the product is to be stored as Liquid Plasma. (b) Fresh Frozen Plasma. Fresh frozen plasma shall be prepared from blood collected by a single uninterrupted venipuncture with minimal damage to and minimal manipulation of the donor's tissue. The plasma shall be separated from the red blood cells, and placed in a freezer within 8 hours or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system, and stored at -18 °C or colder. (c) Liquid Plasma. Liquid Plasma shall be separated from the red blood cells and shall be stored at a temperature of 1 to 6 °C within 4 hours after filling the final container or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system. (d) Platelet Rich Plasma. Platelet rich plasma shall be prepared from blood collected by a single uninterrupted venipuncture with minimal damage to and manipulation of the donor's tissue. The plasma shall be separated from the red blood cells by centrifugation within 4 hours after completion of the phlebotomy or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system. The time and speed of the centrifugation shall have been shown to produce a product with at least 250,000 platelets per microliter. The plasma shall be stored at a temperature between 20 and 24 °C immediately after filling the final container. A gentle and continuous agitation of the product shall be maintained throughout the storage period, if stored at a temperature of 20 to 24 °C. (e) Modifications of Plasma. It is possible to separate Platelets and/or Cryoprecipitated AHF from Plasma. When these components are to be separated, the plasma shall be collected as described in §640.32 for Plasma. (1) Platelets shall be separated as prescribed in subpart C of part 640, prior to freezing the plasma. The remaining plasma may be labeled as “Fresh Frozen Plasma,” if frozen within 6 hours after filling the final container or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system. (2) Cryoprecipitated AHF shall be removed as prescribed in subpart F of part 640. The remaining plasma shall be labeled “Plasma, Cryoprecipitate Reduced.” (3) Plasma remaining after both Platelets and Cryoprecipitated AHF have been removed may be labeled “Plasma, Cryoprecipitate Reduced.” (f) The final container. (1) The final container shall have no color added to the plastic and shall be transparent to permit visual inspection of the contents; any closure shall maintain a hermetic seal and prevent contamination of the contents. (2) The final container material shall not interact with the contents, under the customary conditions of storage and use, in such a manner as to have an adverse effect upon the safety, purity, potency, and effectiveness of the product. (3) Prior to filling, the final container shall be identified by number so as to relate it to the donor. (g) The final product. (1) The final product shall be inspected immediately after separation of the plasma and shall not be issued for transfusion if there is (i) any abnormality in color or physical appearance, or (ii) any indication of contamination. (2) With the exception of Platelet Rich Plasma and Liquid Plasma the final product shall be inspected for evidence of thawing or breakage at the time of issuance, however, the containers need not be stored in a manner that shows evidence of thawing if records of continuous monitoring of the storage temperature establish that the temperature remained at –18 °C or colder. If continuous monitoring of the product is not available, the final product shall be stored in a manner that will show evidence of thawing and shall not be issued if there is any evidence of thawing. (3) No preservative shall be added to the final product. [42 FR 59878, Nov. 22, 1977, as amended at 43 FR 34460, Aug. 4 1978; 48 FR 13026, Mar. 29, 1983; 50 FR 4139, Jan. 29, 1985; 64 FR 45373, Aug. 19, 1999; 66 FR 1836, Jan. 10, 2001; 66 FR 40890, Aug. 6, 2001]
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart D—Plasma
§ 640.30 Plasma.
§ 640.31 Suitability of donors.
§ 640.32 Collection of source material.
§ 640.33 Testing the blood.
§ 640.34 Processing.
