[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.200]

[Page 311-312]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 58_GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
--Table of Contents
 
            Subpart K_Disqualification of Testing Facilities
 
Sec. 58.200  Purpose.


    (a) The purposes of disqualification are:
    (1) To permit the exclusion from consideration of completed studies 
that were conducted by a testing facility which has failed to comply 
with the requirements of the good laboratory practice regulations until 
it can be adequately demonstrated that such noncompliance did not occur 
during, or did not affect the validity or acceptability of data 
generated by, a particular study; and
    (2) To exclude from consideration all studies completed after the 
date of disqualification until the facility can satisfy the Commissioner 
that it will conduct studies in compliance with such regulations.
    (b) The determination that a nonclinical laboratory study may not be 
considered in support of an application for a research or marketing 
permit does not, however, relieve the applicant for

[[Page 312]]

such a permit of any obligation under any other applicable regulation to 
submit the results of the study to the Food and Drug Administration.