In a prepublication Federal Register notice (here), it was announced that the final rule “Nonprescription Drug Product With an Additional Condition for Nonprescription Use” has had its implementation date delayed until March 21, 2025.
According to the notice, the “FDA published a final rule, titled ‘Nonprescription Drug Product With an Additional Condition for Nonprescription Use,’ in the Federal Register on December 26, 2024 (89 FR 105288). That rule was published with an effective date of January 27, 2025. On January 20, 2025, the President issued a memorandum titled, ‘Regulatory Freeze Pending Review.’ With respect to rules that have been published in the Federal Register, but have not taken effect, the memorandum orders agencies consider postponing the rules’ effective dates for 60 days from the date of the memorandum (i.e., until March 21, 2025) for the purpose of reviewing any questions of fact, law, and policy the rules may raise… FDA also believes that affected entities need to be informed as soon as possible of the extension and its length in order to plan and adjust their implementation process accordingly.”
Hopefully after the March date, the ban on communications, issuance of guidances and proposed or final rules, and updating of FDA websites will reverse and the FDA will become more transparent. Right now, we just need to wait for further direction.
