[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: 21CFR58.43]



[Page 306]

 

                        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 C_Facilities

 

Sec.  58.43  Animal care facilities.



    (a) A testing facility shall have a sufficient number of animal 

rooms or areas, as needed, to assure proper: (1) Separation of species 

or test systems, (2) isolation of individual projects, (3) quarantine of 

animals, and (4) routine or specialized housing of animals.

    (b) A testing facility shall have a number of animal rooms or areas 

separate from those described in paragraph (a) of this section to ensure 

isolation of studies being done with test systems or test and control 

articles known to be biohazardous, including volatile substances, 

aerosols, radioactive materials, and infectious agents.

    (c) Separate areas shall be provided, as appropriate, for the 

diagnosis, treatment, and control of laboratory animal diseases. These 

areas shall provide effective isolation for the housing of animals 

either known or suspected of being diseased, or of being carriers of 

disease, from other animals.

    (d) When animals are housed, facilities shall exist for the 

collection and disposal of all animal waste and refuse or for safe 

sanitary storage of waste before removal from the testing facility. 

Disposal facilities shall be so provided and operated as to minimize 

vermin infestation, odors, disease hazards, and environmental 

contamination.



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