Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
fda-food · Food and Drug Administration · Rule · Published 2014-06-10 · Effective 2014-07-10 · 79 FR 33057
Document
Document number
2014-13384
Federal Register citation
79 FR 33057
CFR reference
21 CFR 106
Type
Rule
Action
Final rule.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
2014-06-10
Effective date
2014-07-10
HHS docket
Docket No. FDA-1995-N-0063 (formerly 95N-0309)
Abstract
The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula" (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.