FDA Issues Final Guidance on Exempt Infant Formula Production

Constituent Update

April 14, 2016

The U.S. Food and Drug Administration has issued final guidance for industry on exempt infant formula production to help manufacturers understand suggested manufacturing standards of exempt infant formula in relation to the requirements that apply to non-exempt infant formulas. An exempt infant formula is any infant formula which is represented and labeled for use for an infant who has an inborn error of metabolism or low birth weight, or another unusual medical or dietary problem.

The FDA recognizes that exempt infant formulas may need to differ in their manufacturing from non-exempt infant formulas because of the specific medical conditions for which the infant formula is used. In this final guidance, entitled “Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports,” FDA suggests that manufacturers of exempt infant formula follow, to the extent possible, the standards set in the final rule for infant formula to ensure the safety and nutritional quality of the formulas.

Additional information

• Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports
• Federal Register Notice - Final Rule - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
  Note: Corrections to the final rule were made July 2014. See Federal Register Notice - Final Rule Corrections - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula.