[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: 21CFR660.41]

[Page 117]
 
                        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 E--Hepatitis B Surface Antigen
 
Sec. 660.41  Processing.

    (a) Method. The processing method shall be one that has been shown 
to yield consistently a specific and potent final product, free of 
properties which would adversely affect the test results when the 
product is tested by the methods recommended by the manufacturer in the 
package insert. The product and all ancillary reagents and materials 
supplied in the package with the product shall be manufactured in a 
manner that will reduce the risk of transmitting type B viral hepatitis.
    (b) Ancillary reagents and materials. All ancillary reagents and 
materials supplied in the package with the product shall meet generally 
accepted standards of purity and quality and shall be effectively 
segregated and otherwise manufactured in a manner that will reduce the 
risk of contaminating the product and other biological products. 
Ancillary reagents and materials accompanying the product, which are 
used in the performance of the test as described by the manufacturer's 
recommended test procedures, shall have been shown not to affect 
adversely the product within the prescribed dating period.
    (c) Final container. A final container shall be sufficiently 
transparent to permit visual inspection of the contents for presence of 
particulate matter and increased turbidity. The effectiveness of the 
contents of a final container shall be maintained throughout its dating 
period.
    (d) Date of manufacture. The date of manufacture of Hepatitis B 
Surface Antigen that has been iodinated with radioactive iodine 
(125 I) shall be the day of labeling the antibody with the 
radionuclide.

[44 FR 36382, June 22, 1979, as amended at 49 FR 1685, Jan. 13, 1984]