Amendments to Sterility Test Requirements for Biological Products
other · Food and Drug Administration · Rule · Published 2012-05-03 · Effective 2012-06-04 · 77 FR 26162
Document
Document number
2012-10649
Federal Register citation
77 FR 26162
CFR reference
21 CFR 600
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.