[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: 21CFR58.217]



[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.  58.217  Suspension or termination of a testing facility by a 

sponsor.



    Termination of a testing facility by a sponsor is independent of, 

and neither in lieu of nor a precondition to, proceedings or actions 

authorized by this subpart. If a sponsor terminates or suspends a 

testing facility from further participation in a nonclinical laboratory 

study that is being conducted as part of any application for a research 

or marketing permit that has been submitted to any Center of the Food 

and Drug Administration (whether approved or not), it shall notify that 

Center in writing within 15 working days of the action; the notice shall 

include a statement of the reasons for such action. Suspension or 

termination of a testing facility by a sponsor does not relieve it of 

any obligation under any other applicable regulation to submit the 

results of the study to the Food and Drug Administration.



[43 FR FR 60013, Dec. 22, 1978, as amended at 50 FR 8995, Mar. 6, 1985]