21 CFR 58.43
Animal care facilities
21 CFR 58.43 is the regulation titled “Animal care facilities” in 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 58.107, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
The regulation
Read the text of 21 CFR 58.43 (eCFR, as of Sep 1, 2026)
(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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 58.43.
- 21 CFR 58.107Test and control article handling1 letter cites both
- 21 CFR 58.202Grounds for disqualification1 letter cites both
- 21 CFR 58.33Study director1 letter cites both
- 21 CFR 58.35Quality assurance unit1 letter cites both
- 21 CFR 58.49Laboratory operation areas1 letter cites both
- 21 CFR 58.81Standard operating procedures1 letter cites both
- 21 CFR 58.90Animal care1 letter cites both
Latest letters citing it
The letter citing 21 CFR 58.43 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.