[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: 21CFR58.210]
[Page 315]
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. 58.210 Actions upon disqualification.
(a) Once a testing facility has been disqualified, each application
for a research or marketing permit, whether approved or not, containing
or relying upon any nonclinical laboratory study conducted by the
disqualified testing facility may be examined to determine whether such
study was or would be essential to a decision. If it is determined that
a study was or would be essential, the Food and Drug Administration
shall also determine whether the study is acceptable, notwithstanding
the disqualification of the facility. Any study done by a testing
facility before or after disqualification may be presumed to be
unacceptable, and the person relying on the study may be required to
establish that the study was not affected by the circumstances that led
to the disqualification, e.g., by submitting validating information. If
the study is then determined to be unacceptable, such data will be
eliminated from consideration in support of the application; and such
elimination may serve as new information justifying the termination or
withdrawal of approval of the application.
(b) No nonclinical laboratory study begun by a testing facility
after the date of the facility's disqualification shall be considered in
support of any application for a research or marketing permit, unless
the facility has been reinstated under Sec. 58.219. The determination
that a 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.
[43 FR 60013, Dec. 22, 1978, as amended at 59 FR 13200, Mar. 21, 1994]
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