Secretary of Health and Human Services Robert F. Kennedy Jr. says the Food and Drug Administration needs more time to consider changes to its “additional condition for nonprescription use” final rule before the OTC switch pathway takes effect.
Longer ACNU Rule Review Gets Kennedy Signature
Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.
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FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”