[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: 21CFR660.46]

[Page 128-129]
 
                        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. 660.46  Samples; protocols; official release.

    (a) Samples. (1) For the purposes of this section, a sample of 
product not iodinated with \125\I means a sample from each filling of 
each lot packaged as for distribution, including all ancillary reagents 
and materials; and a sample of product iodinated with \125\I or 
unlyophilized HBsAg-coated red blood cells means a sample from each lot 
of diagnostic test kits in a finished package, including all ancillary 
reagents and materials.
    (2) Unless the Director, Center for Biologics Evaluation and 
Research, determines that the reliability and consistency of the 
finished product can be assured with a smaller quantity of sample or no 
sample and specifically reduces or eliminates the required quantity of 
sample, each manufacturer shall submit the following samples to the 
Director, Center for Biologics Evaluation and Research (see mailing 
addresses in Sec. 600.2 of this chapter), within 5 working days after 
the manufacturer has satisfactorily completed all tests on the samples:

[[Page 129]]

    (i) One sample until written notification of official release is no 
longer required under paragraph (c)(2) of this section.
    (ii) One sample of product at periodic intervals of 90 days, 
beginning after written notification of official release is no longer 
required under paragraph (c)(2) of this section. The sample submitted at 
the 90-day interval shall be from the first lot or filling, as 
applicable, released by the manufacturer, under the requirements of 
Sec. 610.1 of this chapter, after the end of the previous 90-day 
interval. The sample shall be identified as ``surveillance sample'' and 
shall include the date of manufacture.
    (iii) Samples may at any time be required to be submitted to the 
Director, Center for Biologics Evaluation and Research, if the Director 
finds that continued evaluation is necessary to ensure the potency, 
quality, and reliability of the product.
    (b) Protocols. For each sample submitted as required in paragraph 
(a)(1) of this section, the manufacturer shall send a protocol that 
consists of a summary of the history of manufacture of the product, 
including all results of each test for which test results are requested 
by the Director, Center for Biologics Evaluation and Research. The 
protocols submitted with the samples at periodic intervals as provided 
in paragraph (a)(2)(ii) of this section shall be identified by the 
manufacturer as ``surveillance test results.''
    (c) Official release. (1) The manufacturer shall not distribute the 
product until written notification of official release is received from 
the Director, Center for Biologics Evaluation and Research, except as 
provided in paragraph (c)(2) of this section. Official release is 
required for at least five consecutive lots or fillings, as applicable, 
manufactured after licensure of the product.
    (2) After written notification of official release is received from 
the Director, Center for Biologics Evaluation and Research, for at least 
five consecutive lots or fillings manufactured after licensure of the 
products, and after the manufacturer receives from the Director, Center 
for Biologics Evaluation and Research, written notification that 
official release is no longer required, subsequent lots or fillings may 
be released by the manufacturer under the requirements of Sec. 610.1 of 
this chapter.
    (3) The manufacturer shall not distribute lots or fillings, as 
applicable, of products that require sample submission under paragraph 
(a)(2)(iii) of this section until written notification of official 
release or notification that official release is no longer required is 
received from the Director, Center for Biologics Evaluation and 
Research.

[48 FR 20407, May 6, 1983, as amended at 49 FR 23834, June 8, 1984; 51 
FR 15611, Apr. 25, 1986; 55 FR 11013 and 11014, Mar. 26, 1990; 70 FR 
14985, Mar. 24, 2005]