[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: 21CFR58.10]



[Page 304]

 

                        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 A_General Provisions

 

Sec.  58.10  Applicability to studies performed under grants and 

contracts.



    When a sponsor conducting a nonclinical laboratory study intended to 

be submitted to or reviewed by the Food and Drug Administration utilizes 

the services of a consulting laboratory, contractor, or grantee to 

perform an analysis or other service, it shall notify the consulting 

laboratory, contractor, or grantee that the service is part of a 

nonclinical laboratory study that must be conducted in compliance with 

the provisions of this part.