[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: 21CFR660.2]

[Page 119-120]
 
                        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 A_Antibody to Hepatitis B Surface Antigen
 
Sec. 660.2  General requirements.

    (a) Processing. The processing method shall be one that has been 
shown to consistently yield 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 enclosure.
    (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 (such as heating at 60 
[deg]C. for 10 hours) 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 adversely affect the

[[Page 120]]

product within the prescribed dating period.
    (c) Labeling. In addition to the items required by other applicable 
labeling provisions of this subchapter, the following shall also be 
included:
    (1) Indication of the source of the product immediately following 
the proper name on both the final container and package label, e.g., 
human, guinea pig.
    (2) Name of the test method(s) recommended for the product on the 
package label and on the final container label when capable of bearing a 
full label (see Sec. 610.60(a) of this chapter).
    (3) A warning on the package label and on the final container label 
if capable of bearing a full label (see Sec. 610.60(a) of this chapter) 
indicating that the product and antigen if supplied, shall be handled as 
if capable of transmitting hepatitis.
    (4) If the product is dried, the final container label shall 
indicate ``Reconstitution date: ------------'' and a statement 
indicating the period within which the product may be used after 
reconstitution.
    (5) The package shall include a package enclosure providing (i) 
adequate instructions for use, (ii) a description of all recommended 
test methods, and (iii) warnings as to possible hazards, including 
hepatitis, in handling the product and any ancillary reagents and 
materials accompanying the product.
    (d) 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.
    (e) Date of manufacture. The date of manufacture of Antibody to 
Hepatitis B surface Antigen that has been iodinated with radioactive 
iodine (\125\I) shall be the day of labeling the antibody with the 
radionuclide.
    (f) Retention samples. Each manufacturer shall retain representative 
samples of the product in accordance with Sec. 600.13 of this chapter 
except for that which has been iodinated with radioactive iodine. 
Retention samples of Antibody to Hepatitis B Surface Antigen iodinated 
with \125\I shall consist of a minimum of two complete finished packages 
of each lot of the diagnostic test kit and shall be retained for a 
period of at least 90 days from the date of manufacture.

[38 FR 32098, Nov. 20, 1973, as amended at 40 FR 29711, July 15, 1975; 
46 FR 36134, July 14, 1981; 49 FR 1684, Jan. 13, 1984]