This electronic document was downloaded from the GPO web site, September 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[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: 21CFR58.43]
[Page 313]
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]
[[Page 314]]