Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=se21.7.606_1121&rgn=div8
Timestamp: 2020-06-01 01:58:46
Document Index: 735234101

Matched Legal Cases: ['art 606', '§606', '§606', '§610', '§640', '§610', '§640', '§610', '§610', '§610', '§630', '§610', '§610']

Title 21 → Chapter I → Subchapter F → Part 606 → Subpart G → §606.121
Subpart G—Additional Labeling Standards for Blood and Blood Components
§606.121 Container label.
(5) For Whole Blood, Plasma, Platelets, and partial units of Red Blood Cells, the volume of the product, accurate to within ±10 percent; or optionally for Platelets, the volume or volume range within reasonable limits.
(ii) If the test using Anti-D Blood Grouping Reagent is negative, but the test for weak D (formerly Du) is positive, the product must be labeled: “Rh positive.”
(11) If the product is intended for further manufacturing use, a statement listing the results of all the tests for relevant transfusion-transmitted infections required under §610.40 of this chapter for which the donation has been tested and found negative; except that the container label for Source Plasma is not required to list the negative results of serological syphilis testing under §640.65(b) of this chapter.
(12) The blood and blood components must be labeled in accordance with §610.40 of this chapter, when the donation is tested and demonstrates evidence of infection due to a relevant transfusion-transmitted infection(s).
(ii) The statement “Store at −20 °C or colder,” provided, that where plasma is intended for manufacturing into noninjectable products, this statement may be replaced by a statement of the temperature appropriate for manufacture of the final product to be prepared from the plasma.
(v) Source Plasma diverted for Source Plasma Salvaged must be relabeled “Source Plasma Salvaged” as prescribed in §640.76 of this chapter. Immediately following the proper name of the product, with any appropriate modifiers and attributes, the labeling must prominently state as applicable, “STORAGE TEMPERATURE EXCEEDED −20 °C” or “SHIPPING TEMPERATURE EXCEEDED −5 °C.”
(f) Blood and blood components determined to be unsuitable for transfusion must be prominently labeled “NOT FOR TRANSFUSION,” and the label must state the reason the unit is considered unsuitable. The provision does not apply to blood and blood components intended solely for further manufacture.
(h) The following additional information must appear on the label for blood and blood components shipped in an emergency prior to completion of required tests, in accordance with §610.40(g) of this chapter:
(1) The statement: “FOR EMERGENCY USE ONLY BY __ .”
(2) Results of any tests prescribed under §§610.40 and 640.5(b) or (c) of this chapter completed before shipment.
(3) Indication of any tests prescribed under §§610.40 and 640.5(b) or (c) of this chapter not completed before shipment.
(3) The statement: “AUTOLOGOUS DONOR.”
(5) Each container of blood and blood component intended for autologous use and obtained from a donor who fails to meet any of the donor eligibility requirements under §630.10 of this chapter or who is reactive to or positive for one or more tests for evidence of infection due to relevant transfusion-transmitted infections under §610.40 of this chapter must be prominently and permanently labeled “FOR AUTOLOGOUS USE ONLY” and as otherwise required under §610.40 of this chapter. Such units also may have the ABO and Rh blood group and type on the label.