[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: 21CFR660.36]

[Page 127]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 660_ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--
 
                    Subpart D_Reagent Red Blood Cells
 
Sec. 660.36  Samples and protocols.

    (a) The following shall be submitted to the Center for Biologics 
Evaluation and Research Sample Custodian (ATTN: HFM-672) (see mailing 
addresses in Sec. 600.2 of this chapter), within 30 days after each 
routine establishment inspection by FDA.
    (1) From a lot of final product, samples from a cell panel intended 
for identification of unexpected antibodies. The sample shall be 
packaged as for distribution and shall have at least 14 days remaining 
in the dating period when shipped to the Center for Biologics Evaluation 
and Research.
    (2) A protocol which shall include the following:
    (i) Complete test records of at least two donors of the samples 
submitted, including original and confirmation phenotyping records.
    (ii) Bleeding records or receipt records which indicate collection 
date, volume, and HBsAg test results.
    (iii) Manufacturing records which document all steps involved in the 
preparation of the product.
    (iv) Test results which verify that the final product meets 
specifications.
    (v) Identity test results.
    (b) A copy of the antigenic constitution matrix specifying the 
antigens present or absent shall be submitted to the Director, Center 
for Biologics Evaluation and Research, at the time of initial 
distribution of each lot of Reagent Red Blood Cells for detection or 
identification of unexpected antibodies. Products designed exclusively 
to identify Anti-A, Anti-A1, and Anti-B, as well as products 
composed entirely of umbilical cord cells, are excluded from this 
requirement.
    (c) Except for umbilical cord samples, whenever a new donor is used, 
a sample of red blood cells from each new donor used in a cell panel 
intended for the identification of unexpected antibodies shall be 
submitted by the manufacturer to the Director, Center for Biologics 
Evaluation and Research. The sample should contain a minimum volume of 
0.5 milliliter of red blood cells.

[52 FR 37450, Oct. 7, 1987, as amended at 55 FR 11013 and 11015, Mar. 
26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 24, 2005]