[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: 21CFR58.90]
 
[Page 315-316]
 
                        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 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.
 
[[Page 316]]
 
    (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]