[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: 21CFR58.215]



[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 Contents

 

            Subpart K_Disqualification of Testing Facilities

 

Sec.  58.215  Alternative or additional actions to disqualification.



    (a) Disqualification of a testing facility under this subpart is 

independent of, and neither in lieu of nor a precondition to, other 

proceedings or actions authorized by the act. The Food and Drug 

Administration may, at any time, institute against a testing facility 

and/or against the sponsor of a nonclinical laboratory study that has 

been submitted to the Food and Drug Administration any appropriate 

judicial proceedings (civil or criminal) and any other appropriate 

regulatory action, in addition to or in lieu of, and prior to, 

simultaneously with, or subsequent to, disqualification. The Food and 

Drug Administration may also refer the matter to another Federal, State, 

or local government law enforcement or regulatory agency for such action 

as that agency deems appropriate.

    (b) The Food and Drug Administration may refuse to consider any 

particular nonclinical laboratory study in support of an application for 

a research or marketing permit, if it finds that the study was not 

conducted in accordance with the good laboratory practice regulations 

set forth in this part, without disqualifying the testing facility that 

conducted the study or undertaking other regulatory action.