[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: 21CFR58.107]



[Page 309]

 

                        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 F_Test and Control Articles

 

Sec.  58.107  Test and control article handling.



    Procedures shall be established for a system for the handling of the 

test and control articles to ensure that:

    (a) There is proper storage.

    (b) Distribution is made in a manner designed to preclude the 

possibility of contamination, deterioration, or damage.

    (c) Proper identification is maintained throughout the distribution 

process.

    (d) The receipt and distribution of each batch is documented. Such 

documentation shall include the date and quantity of each batch 

distributed or returned.