Type of Posting: Notice of Intent to Revise
Posting Date: 27-Oct-2023
Targeted Official Date: 01-Jan-2024; Revision Bulletin
Expert Committee: Small Molecules 4
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the text regarding compendial applicability of <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging, consistent with recent changes made in General Chapters <795> and <797>.
The current version of <825>, which became official on December 1, 2020 via Revision Bulletin, contains text that indicates that the Chapter is not compendially applicable. The intent is to delete this text. General Chapter <825> is now compendially applicable because it is referenced in both <795> and <797> which are applicable general chapters numbered below 1000 that become official on November 1, 2023. This means that regulatory bodies with jurisdiction over compounded radiopharmaceuticals, and that require compliance with the requirements in the USP-NF, may require compliance with requirements in <825>.
It is anticipated that the proposed revision will be published as a Revision Bulletin pursuant to the Rules and Procedures on December 29, 2023.
Should you have any questions, please contact Gerald Hsu, Principal Scientist (gdh@usp.org).