[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.70]

[Page 110-111]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of 
 
                         Subpart G_Source Plasma
 
Sec. 640.70  Labeling.

    (a) In addition to the labeling requirements of Sec. 610.62 of this 
chapter, and in lieu of the requirements in Sec. Sec. 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

[[Page 111]]

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 
Sec. 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 Sec. 610.40 of this 
chapter, the Source Plasma must be labeled under Sec. 
610.40(h)(2)(ii)(E) of this chapter.
    (3) The statement ``Store at -20 [deg]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 HBs Ag 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 Sec. 640.76. 
Immediately following the proper name of the product, the labeling shall 
conspicuously state as applicable, ``STORAGE TEMPERATURE EXCEEDED -20 
[deg]C'' or ``SHIPPING TEMPERATURE EXCEEDED -5 [deg]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]