[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR58.200]



[Page 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 such a permit of any 

obligation under any other applicable regulation to submit the results 

of the study to the Food and Drug Administration.