New guidance for notifying permanent discontinuation of infant formula manufacturing
USA
Dec 04, 2024
The Food and Drug Administration (FDA) has issued draft guidance outlining the requirements and procedures that infant formula manufacturers should follow to notify the FDA of a permanent discontinuance or an interruption of the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the United States. The draft guidance titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula” is intended to help the infant formula industry comply with section 424 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350m) which requires, in part, infant formula manufacturers to notify the FDA of a permanent discontinuance in the manufacture or an interruption of the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the United States.
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