[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR660.21]

[Page 110-111]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--Table of Contents
 
                    Subpart C--Blood Grouping Reagent
 
Sec. 660.21  Processing.

    (a) Processing method. (1) The processing method shall be one that 
has been shown to yield consistently a specific, potent final product, 
free of properties that would affect adversely the

[[Page 111]]

intended use of the product throughout its dating period. Stability 
testing shall be performed on an adequate number of representative 
samples of each group of products manufactured in the same fashion.
    (2) Only that material that has been fully processed, thoroughly 
mixed in a single vessel, and sterile filtered shall constitute a lot.
    (3) A lot may be subdivided into clean, sterile vessels. Each 
subdivision shall constitute a sublot. If lots are to be subdivided, the 
manufacturer shall include this information in the biologics license 
application. The manufacturer shall describe the test specifications to 
verify that each sublot is identical to other sublots of the lot.
    (4) Each lot of Blood Grouping Reagent shall be identified by a lot 
number. Each sublot shall be identified by that lot number to which a 
distinctive prefix or suffix shall be added. Final container and package 
labels shall bear the lot number and all distinctive prefixes and 
suffixes that have been applied to identify the sublot from which 
filling was accomplished.
    (b) Color coding of reagents. Blood Grouping Reagents may be colored 
provided the added colorant does not adversely affect the safety, 
purity, or potency of the product and the colorant is approved by the 
Director, Center for Biologics Evaluation and Research (HFN-830), Food 
and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892.
    (c) Final containers and dropper assemblies. Final containers and 
dropper pipettes shall be colorless and sufficiently transparent to 
permit observation of the contents to detect particulate matter or 
increased turbidity during use.
    (d)  Volume of final product. Each manufacturer shall identify the 
possible final container volumes in the biologics license application.
    (e) Date of manufacture. The date of manufacture shall be the date 
the manufacturer begins the last entire group of potency tests.

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0209)

[53 FR 12764, Apr. 19, 1988, as amended at 64 FR 56454, Oct. 20, 1999]

    Effective Date Note: At 65 FR 77499, Dec. 12, 2000, 
Sec. 660.21(a)(2) was amended by removing the word ``sterile''; and in 
paragraph (a)(3) by removing the words ``clean, sterile vessels. Each 
subdivision shall constitute a sublot'' and adding in its place the word 
``sublots'', effective June 11, 2001.