21 CFR 211.173 - Laboratory Animals

What it says

Animals used in testing components, in-process materials or drug products for compliance with established specifications must be maintained and controlled in a manner that assures their suitability for their intended use. They must be identified, and adequate records must be maintained showing the history of their use.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It applies where animal-based tests, such as certain pyrogen or potency tests, are part of the release testing.
• Housing, care and identification of animals affect the validity of results.
• Use history records help show that an animal was suitable for a given test.

What FDA inspectors look for

• Whether animals are identified and their history of use recorded.
• Whether conditions of housing and care are controlled.
• Whether test results are backed by records of animal suitability.

Related regulations