§ 640.70 - Labeling.

Link to an amendment published at 77 FR 18, Jan. 3, 2012.

(a) In addition to the labeling requirements of §610.62 of this chapter, and in lieu of the requirements in §§606.121, 610.60, and 610.61 of this chapter, the following information shall appear on the label affixed to each container of Source Plasma:

(1) The proper name of the product.

(2) The statement “Caution: For Manufacturing Use Only” for products intended for further manufacturing into injectable products, or the statement, “Caution: For Use In Manufacturing Noninjectable Products Only”, for products intended for further manufacturing into noninjectable products. The statement shall follow the proper name in the same size and type of print as the proper name. If the Source Plasma has a reactive screening test for evidence of infection due to a communicable disease agent(s) under §610.40 of this chapter, or is collected from a donor with a previous record of a reactive screening test for evidence of infection due to a communicable disease agent(s) under §610.40 of this chapter, the Source Plasma must be labeled under §610.40(h)(2)(ii)(E) of this chapter.

(3) The statement “Store at −20 °C or colder”: Provided, That where plasma is intended for manufacturing into noninjectable products, this statement may be omitted if replaced by a statement of the temperature appropriate for the final product to be prepared from the plasma.

(4) The total volume or weight of plasma and total quantity and type of anticoagulant used.

(5) The donor number or individual bleed number, or both. If plasma is pooled from two or more donors, either all donor numbers, all bleed numbers, or a pool number that is traceable to each individual unit comprising the pool.

(6) The expiration date of the plasma. If plasma intended for manufacturing into noninjectable products is pooled from two or more donors the expiration date is determined from the collection date of the oldest unit in the pool, and the pooling records shall show the collection date for each unit constituting the pool.

(7) A statement as to whether the plasma was collected from normal donors or from immunized donors. In the case of immunized donors, the label shall state the immunizing antigen.

(8) The test for hepatitis B surface antigen used for the results, or the statement “Nonreactive for HB_sAg by FDA required test”.

(9) When plasma collected from a donor is reactive for the serologic test for syphilis, a statement that the plasma is reactive and must be used only for the manufacturing of positive control reagents for the serologic test for syphilis.

(10) Name, address, and license number of the manufacturer.

(11) The statement “Negative by a test for antibody to HIV”, or equivalent statement.

(b) Source Plasma diverted for Source Plasma Salvaged shall be relabeled “Source Plasma Salvaged” as prescribed in §640.76. Immediately following the proper name of the product, the labeling shall conspicuously state as applicable, “STORAGE TEMPERATURE EXCEEDED −20 °C” or “SHIPPING TEMPERATURE EXCEEDED −5 °C”.

[41 FR 10770, Mar. 12, 1976, as amended at 41 FR 27034, July 1, 1976; 41 FR 35062, Aug. 19, 1976; 47 FR 30969, July 16, 1982; 50 FR 4140, Jan. 29, 1985; 50 FR 35471, Aug. 30, 1985; 53 FR 117, Jan. 5, 1988; 63 FR 16685, Apr. 6, 1998; 66 FR 31165, June 11, 2001]