# Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications
> **Food and Drug Administration** · Final rule. · Published 2015-07-02 · Effective 2015-08-03 · 80 FR 37971
## Document
- **Document number:** 2015-16366
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 80 FR 37971
- **CFR reference:** 21 CFR 601
- **Publication date:** 2015-07-02
- **Effective date:** 2015-08-03
- **HHS docket:** Docket No. FDA-2014-N-1110
## Abstract

The Food and Drug Administration (FDA) is amending the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is finalizing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics license applications (BLAs), or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to the Executive order.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2015/07/02/2015-16366/revocation-of-general-safety-test-regulations-that-are-duplicative-of-requirements-in-biologics)
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