This electronic document was downloaded from the GPO web site, September 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.217]
[Page 321]
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]