[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: 21CFR660.51]

[Page 119]
 
                        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 F--Anti-Human Globulin
 
Sec. 660.51  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 adversely affect the product for its 
intended use throughout its dating period.
    (2) Anti-IgG, -C3d (polyspecific) reagents and anti-IgG products may 
be colored green.
    (3) Only that material which has been fully processed, thoroughly 
mixed in a single vessel, and sterile filtered shall constitute a lot. 
Each lot shall be identified by a lot number.
    (4) A lot may be subdivided into clean, sterile vessels. Each 
subdivision shall constitute a sublot which shall be identified by the 
lot number to which has been added a distinctive prefix or suffix. If 
lots are to be subdivided, the manufacturer shall include this 
information in the license application and on the protocol. The 
manufacturer shall describe the test specifications to verify that each 
sublot is identical to other sublots of the lot.
    (b) Final containers and dropper assemblies. (1) Final containers 
and dropper assemblies shall be clean.
    (2) Final containers and dropper pipettes shall be colorless and 
sufficiently transparent to permit observation of the contents for 
presence of particulate matter or increased turbidity.
    (c) Date of manufacture. The date of manufacture shall be the date 
the manufacturer begins the last entire group of potency tests.

(Approved by the Office of Management and Budget under control number 
0910-0208)

[50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985]

    Effective Date Note: At 65 FR 77499, Dec. 12, 2000, 
Sec. 660.51(a)(3) was amended by removing the word ``sterile''; and in 
paragraph (a)(4) by removing the words ``clean, sterile vessels. Each 
subdivision shall constitute a sublot'' and adding in its place the word 
``sublots'', and in the third sentence by removing the words ``and on 
the protocol'', effective June 11, 2001.