FDA Adopts Final Infant Formula Manufacturing Requirements
The Food and Drug Administration is adopting as final its interim regulations that established current good manufacturing practice (CGMP) requirements for infant formula. FDA is making some changes to the interim regulations, including provisions for an exemption from infant formula testing if the manufacturer or importer can show the new formula wouldn’t differ from a similar formula that’s already on the market. Manufacturers are required to comply with the new regulations by Sept. 8, 2014, except for some provisions which are getting a grace period until Nov. 12, 2015.
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The infant formula CGMP regulations require that manufacturers of infant formula develop a written plan for all stages of production, including during packaging and labeling, to control risks of adulteration and contamination by microorganisms, said FDA in its February interim final rule that’s now being adopted (see 14020611). Infant formula will have to be coded with a sequential number that permits identification of the product, including the packing location and tracing all stages of manufacture, it said.
In a concurrent Federal Register notice (here), FDA announced a final guidance document explaining how some “eligible” infant formula manufacturers can demonstrate that their products meet the quality factor requirements of the final rule. The guidance (here) applies to infant formulas "that are the subject of a premarket notification submitted prior to" Sept. 8, said FDA in a constituent update (here).
(Federal Register 06/10/14)