U.S. Food and Drug Administration Good Laboratory Practice for
Nonclinical Laboratory Studies
(FDA GLPs)
21 C.F.R. 58 (Sections related to animal care and use)
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.1]
Subpart A--General Provisions
Sec. 58.1 Scope
(a) This part prescribes good laboratory practices for conducting nonclinical laboratory
studies that support or are intended to support applications for research or marketing
permits for products regulated by the Food and Drug Administration, including food
and color additives, animal food additives, human and animal drugs, medical devices
for human use, biological products, and electronic products. Compliance with this
part is intended to assure the quality and integrity of the safety data filed pursuant
to sections 406, 408, 409, 502, 503, 505, 506, 510, 512-516, 518-520, 721, and 801
of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the
Public Health Service Act.
(b) References in this part to regulatory sections of the Code of Federal Regulations
are to chapter I of title 21, unless otherwise noted.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 64 FR 399,
Jan. 5, 1999]
Sec. 58.15 Inspection of a testing
facility.
(a) A testing facility shall permit an authorized employee of the Food and Drug
Administration, at reasonable times and in a reasonable manner, to inspect the facility
and to inspect (and in the case of records also to copy) all records and specimens
required to be maintained regarding studies within the scope of this part. The records
inspection and copying requirements shall not apply to quality assurance unit records
of findings and problems, or to actions recommended and taken.
(b) The Food and Drug Administration will not consider a nonclinical laboratory
study in support of an application for a research or marketing permit if the testing
facility refuses to permit inspection. The determination that a nonclinical laboratory
study will not be considered in support of an application for a research or marketing
permit does not, however, relieve the applicant for such a permit of any obligation
under any applicable statute or regulation to submit the
results of the study to the Food and Drug Administration.
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]
Sec. 58.45 Animal supply facilities.
There shall be storage areas, as needed, for feed, bedding, supplies, and equipment.
Storage areas for feed and bedding shall be separated from areas housing the test
systems and shall be protected against infestation or contamination. Perishable
supplies shall be preserved by appropriate means.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]
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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