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 2014-02-10 · Effective 2014-07-10 · 79 FR 7934
Document
Document number
2014-02148
Federal Register citation
79 FR 7934
CFR reference
21 CFR 106
Type
Rule
Action
Interim final rule; request for comments.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
2014-02-10
Effective date
2014-07-10
HHS docket
Docket No. FDA-1995-N-0036 (formerly 95N-0309)
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is revising our infant formula regulations to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.