# Amendments to Sterility Test Requirements for Biological Products
> **Food and Drug Administration** · Final rule. · Published 2012-05-03 · Effective 2012-06-04 · 77 FR 26162
## Document
- **Document number:** 2012-10649
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 77 FR 26162
- **CFR reference:** 21 CFR 600
- **Publication date:** 2012-05-03
- **Effective date:** 2012-06-04
- **HHS docket:** Docket No. FDA-2011-N-0080
## Abstract

The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of- the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2012/05/03/2012-10649/amendments-to-sterility-test-requirements-for-biological-products)
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