[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
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 Contents
 
            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]