Revision to the General Safety Requirements for Biological Products
other · Food and Drug Administration · Rule · Published 2003-03-04 · Effective 2003-05-05 · 68 FR 10157
Document
Document number
03-4973
Federal Register citation
68 FR 10157
CFR reference
21 CFR 610
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.