[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: 21CFR660.41]

[Page 127-128]
 
                        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 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

[[Page 128]]

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]