[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.217]

[Page 316]
 
                        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]