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Summary: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula (Interim Final Rule)

Summary: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula (Interim Final Rule)

Summary:

The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 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.

Regulatory Impact Analysis

Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula (Interim Final Rule)

Federal Register: 79 FR7933, February 10, 2014

Docket: FDA-1995-N-0063