[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.200]
[Page 314]
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
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.
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