21 CFR Part 58 · Good Laboratory Practice for Nonclinical Laboratory Studies

§ 58.43 Animal care facilities

Subpart C - Facilities Official text on eCFR Amendment history

(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.

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Warning letters citing § 58.43

1 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 58.43

Amendment history

Federal Register documents that created or amended this section.