Type of Posting: Notice of Intent to Revise
Posting Date: 28–Dec–2018
Targeted Official Date: 01–Mar–2019, Cancellation of Intent to Postpone.
Expert Committee: Non-Botanical Dietary Supplements
In accordance with section 7.04 (c) of the 2015–2020 Rules and Procedures of the Council of Experts, on July 27, 2018, USP published a Notice of Intent to Revise indicating that the Non-Botanical Dietary Supplements Expert Committee intended to postpone the official date of the revision to the Phytonadione monograph, published in Second Supplement to USP 41–NF 36.
USP has received further communications from FDA indicating that at this time the Agency has no objections with to proceeding with the revision to the chemical structure, chemical name, and CAS number of phytonadione in Second Supplement to USP 41–NF 36. Therefore, this notice serves as a cancellation of the previous notice of intent to postpone the official date of the Chemical Information section of the Phytonadione monograph pending FDA’s decision.
Thus, the aforementioned revision is continuing its course to become official on March 1, 2019, as it is no longer anticipated to publish a Revision Bulletin with the postponement of the section.
Please note that because the Second Supplement to USP 41–NF 36 was not available on the regular posting date of June 1, and to give users additional time to adjust to the new website before implementation, the official date of the Second Supplement to USP 41–NF 36 was delayed by three months from December 1, 2018 until March 1, 2019. For more information on the launch of the new USP–NF Online Launch please see this Notice.
Should you have any questions, please contact Kit Goldman, Director Dietary Supplements and Herbal Medicines (301–692–3597 or kit.goldman@usp.org.)
CN-19-004-01