[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: 21CFR58.210]



[Page 313]

 

                        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]