Food and Drug Administration, HHS § 640.65

cells and plasma against contamina- (2)(i) The accumulated laboratory tion. data, including tracings, if any, of the plasma or serum protein electro- [38 FR 32089, Nov. 20, 1973; 39 FR 13632, Apr. phoresis pattern, the calculated values 16, 1974, as amended at 41 FR 10768, Mar. 12, 1976; 49 FR 23834, June 8, 1984; 50 FR 4140, of each component, and the collection Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR records shall be reviewed by a qualified 49351, Sept. 28, 1994; 63 FR 16685, Apr. 6, 1998; licensed physician within 21 days after 64 FR 56453, Oct. 20, 1999; 72 FR 45888, Aug. 16, the sample is drawn to determine 2007] whether or not the donor may continue in the program. The review shall be § 640.65 Plasmapheresis. signed by the reviewing physician. If (a) Procedure-general. The plasma- the protein composition is not within pheresis procedure is a procedure in normal limits established by the test- which, during a single visit to the es- ing laboratory, or if the total protein is tablishment, blood is removed from a less than 6.0 grams per 100 milliliters of donor, the plasma separated from the samples, the donor shall be removed formed elements, and at least the red from the program until these values re- blood cells returned to the donor. This turn to normal. procedure shall be described in detail (ii) A donor with a reactive serologic in the biologics license application. test for syphilis shall not be (b) Procedures-specific requirements. plasmapheresed again until the donor’s The plasmapheresis procedure shall serum is tested and found to be non- meet the following requirements: reactive to a serologic test for syphilis, except as provided in paragraph (b)(2) (1)(i) A sample of blood shall be (iii) and (iv) of this section. drawn from each donor on the day of (iii) A donor whose serum is deter- the first medical examination or plas- mined to have a biologic false-positive mapheresis, whichever comes first and reaction to a serologic test for syphilis at least every 4 months thereafter by a may be plasmapheresed: Provided, That qualified licensed physician or by per- the donor’s file identifies the serologic sons under his supervision and trained test for syphilis and results used to in such procedure. A serologic test for confirm the biologic false-positive re- syphilis, a total plasma or serum pro- action and indicates that the physician tein determination, and a plasma or on the premises has determined the serum protein electrophoresis or quan- false-positive reaction is not the result titative immuno-diffusion test or an of an underlying disorder that would equivalent test to determine disqualify the donor from participation immunoglobulin composition of the in the plasmapheresis program. If the plasma or serum shall be performed on serologic test for syphilis is performed the sample. at a facility other than the plasma- (ii) A repeat donor who does not re- pheresis center, all applicable provi- turn for plasmapheresis at the time the sions of § 640.71 shall be met. 4-month sample is due to be collected (iv) A donor with a reactive serologic may be plasmapheresed on the day he test for syphilis may be appears: Provided, That no longer than plasmapheresed only to obtain plasma 6 months has elapsed since the last to be used for further manufacturing sample was collected, and the physi- into control serum for the serologic cian on the premises approves the plas- test for syphilis: Provided, That the mapheresis procedure and so indicates physician on the premises approves the by signing the donor’s record before donation, the donor’s file contains a such procedure is performed. The sam- signed statement from a physician or ple for the 4–month tests shall be col- clinic establishing that treatment for lected on the day of the donor’s return. syphilis has been initiated and that (iii) A repeat donor from whom the continuance in the plasmapheresis pro- plasmapheresis center is unable to ob- gram will not interfere with or jeop- tain a sample for testing as prescribed ardize the treatment of the syphilitic in paragraph (b)(1)(i) of this section for donor. a total period exceeding 6 months shall (3) A donor identification system be processed as a new donor. shall be established that positively

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identifies each donor and relates such § 640.66 Immunization of donors. donor directly to his blood and its com- ponents as well as to his accumulated If specific immunization of a donor is records and laboratory data. Such sys- to be performed, the selection and tem shall include either a photograph scheduling of the injection of the anti- of each donor which shall be used on gen, and the evaluation of each donor’s each visit to confirm the donor’s iden- clinical response, shall be by a quali- tity, or some other method that pro- fied licensed physician or physicians. vides equal or greater assurance of The administration of the antigen may positively identifying the donor. be performed by a licensed physician or (4) The amount of whole blood, not a trained person under his supervision. including anticoagulant, removed from Any material used for immunization a donor during a manual plasma- shall be either a product licensed under pheresis procedure or in any 2-day pe- section 351 of the Public Health Service riod shall not exceed 1,000 milliliters Act for such purpose or one specifically unless the donor’s weight is 175 pounds approved by the Director, Center for or greater, in which case the amount of Biologics Evaluation and Research, whole blood, not including anticoagu- Food and Drug Administration. Immu- lant, removed from the donor during a nization procedures shall be on file at manual plasmapheresis procedure or in each plasmapheresis center where im- any 2-day period shall not exceed 1,200 munizations are performed. milliliters. [38 FR 32089, Nov. 20, 1973, as amended at 49 (5) The amount of whole blood, not FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, including anticoagulant, removed from 1990] a donor during a manual plasma- pheresis procedure within a 7-day pe- § 640.67 Laboratory tests. riod shall not exceed 2,000 milliliters Each unit of Source Plasma shall be unless the donor’s weight is 175 pounds tested for evidence of infection due to or greater, in which case the amount of communicable disease agents as re- whole blood, not including anticoagu- quired under § 610.40 of this chapter. lant, removed from a donor during a manual plasmapheresis procedure [66 FR 31165, June 11, 2001] within a 7-day period shall not exceed 2,400 milliliters. § 640.68 Processing. (6) No more than 500 milliliters of (a) Sterile system. All administration whole blood shall be removed from a and transfer sets inserted into blood donor at one time, unless the donor’s containers used for processing Source weight is 175 pounds or greater, in Plasma intended for manufacturing which case no more than 600 milliliters into injectable or noninjectable prod- of whole blood shall be removed from ucts and all interior surfaces of plasma the donor at one time. containers used for processing Source (7) The plasma shall be separated Plasma intended for manufacturing from the red blood cells immediately into injectable products shall be ster- after blood collection. The maximum ile, pyrogen-free, nontoxic, and com- feasible volume of red blood cells shall patible with the contents under normal be returned to the donor before another conditions of use. Only Sodium Chlo- unit is collected. ride Injection USP shall be used as a (8) The volume of plasma collected red blood cell diluent. If the method of during an automated plasmapheresis separation of the plasma intended for collection procedure shall be con- injectable products involves a system sistent with the volumes specifically in which an airway must be inserted approved by the Director, Center for into the plasma container, the airway Biologics Evaluation and Research, and shall be sterile and constructed so as to collection shall not occur less than 2 exclude microorganisms and maintain days apart or more frequently than a sterile system. twice in a 7-day period. (b) Final containers. Final containers [38 FR 32089, Nov. 20, 1973, as amended at 41 used for Source Plasma, whether inte- FR 10769, Mar. 12, 1976; 64 FR 45373, Aug. 19, grally attached or separated from the 1999; 64 FR 56453, Oct. 20, 1999] original blood container, shall not be

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