Amendments to Sterility Test Requirements for Biological Products; Correction
other · Food and Drug Administration · Rule · Published 2012-05-24 · Effective 2012-06-04 · 77 FR 30887
Document
Document number
2012-12594
Federal Register citation
77 FR 30887
CFR reference
21 CFR 600
Type
Rule
Action
Final rule, correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-05-24
Effective date
2012-06-04
HHS docket
Docket No. FDA-2011-N-0080
Abstract
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final 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. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.