# Revision to the General Safety Requirements for Biological Products
> **Food and Drug Administration** · Final rule. · Published 2003-03-04 · Effective 2003-05-05 · 68 FR 10157
## Document
- **Document number:** 03-4973
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 10157
- **CFR reference:** 21 CFR 610
- **Publication date:** 2003-03-04
- **Effective date:** 2003-05-05
- **HHS docket:** Docket No. 97N-0449
## Abstract

The Food and Drug Administration (FDA) is amending the biologics regulations regarding general biological products standards by adding an administrative procedure for obtaining exemptions from the general safety test (GST) requirements. We are taking this action because the GST may not be relevant or necessary for certain biological products. The rule will permit manufacturers of biological products to apply for an exemption from the GST requirement provided they submit information to demonstrate that they use appropriate production controls and quality assurance safeguards.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/03/04/03-4973/revision-to-the-general-safety-requirements-for-biological-products)
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