21 C.F.R. § 640.21 Suitability of donors.
Title 21 - Food and Drugs
(a) Whole blood donors shall meet the criteria for suitability prescribed in §640.3. (b) Plasmapheresis donors shall meet the criteria for suitability prescribed in §640.63, excluding the phrase “other than malaria” in paragraph (c)(9). Informed consent shall be required as prescribed in §640.61. (c) Plateletpheresis donors shall meet criteria for suitability as described in a biologics license application or a supplement to the biologics license application, and must have the written approval of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. [40 FR 4304, Jan. 29, 1975, as amended at 49 FR 23834, June 8, 1984; 64 FR 56453, Oct. 20, 1999]
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart C—Platelets
§ 640.21 Suitability of donors.
