[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: 21CFR58.90]



[Page 308]

 

                        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 E_Testing Facilities Operation

 

Sec.  58.90  Animal care.



    (a) There shall be standard operating procedures for the housing, 

feeding, handling, and care of animals.

    (b) All newly received animals from outside sources shall be 

isolated and their health status shall be evaluated in accordance with 

acceptable veterinary medical practice.

    (c) At the initiation of a nonclinical laboratory study, animals 

shall be free of any disease or condition that might interfere with the 

purpose or conduct of the study. If, during the course of the study, the 

animals contract such a disease or condition, the diseased animals shall 

be isolated, if necessary. These animals may be treated for disease or 

signs of disease provided that such treatment does not interfere with 

the study. The diagnosis, authorizations of treatment, description of 

treatment, and each date of treatment shall be documented and shall be 

retained.

    (d) Warm-blooded animals, excluding suckling rodents, used in 

laboratory procedures that require manipulations and observations over 

an extended period of time or in studies that require the animals to be 

removed from and returned to their home cages for any reason (e.g., cage 

cleaning, treatment, etc.), shall receive appropriate identification. 

All information needed to specifically identify each animal within an 

animal-housing unit shall appear on the outside of that unit.

    (e) Animals of different species shall be housed in separate rooms 

when necessary. Animals of the same species, but used in different 

studies, should not ordinarily be housed in the same room when 

inadvertent exposure to control or test articles or animal mixup could 

affect the outcome of either study. If such mixed housing is necessary, 

adequate differentiation by space and identification shall be made.

    (f) Animal cages, racks and accessory equipment shall be cleaned and 

sanitized at appropriate intervals.

    (g) Feed and water used for the animals shall be analyzed 

periodically to ensure that contaminants known to be capable of 

interfering with the study and reasonably expected to be present in such 

feed or water are not present at levels above those specified in the 

protocol. Documentation of such analyses shall be maintained as raw 

data.

    (h) Bedding used in animal cages or pens shall not interfere with 

the purpose or conduct of the study and shall be changed as often as 

necessary to keep the animals dry and clean.

    (i) If any pest control materials are used, the use shall be 

documented. Cleaning and pest control materials that interfere with the 

study shall not be used.



[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 

54 FR 15924, Apr. 20, 1989; 56 FR 32088, July 15, 1991; 67 FR 9585, Mar. 

4, 2002]



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