Type of Posting: Notice of Intent to Revise
Posting Date: 22–May–2020
Targeted Official Date: 1–Dec–2020
Expert Committee: Various
In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs in response to the revision of General Chapter <1079> Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products.
General Chapter <1079> was proposed for comment in Pharmacopeial Forum 45(5) and will appear in USP 43–NF 38 Second Supplement. USP has identified other documentary standards that reference General Chapter <1079> and thus require revision to modify these references. These references will be updated when the General Chapter appears in USP 43–NF 38 Second Supplement. A list of the monographs that will be modified can be found here
All modifications will become official on December 1, 2020, to coincide with the official date of revised General Chapter <1079>.
Please also see the Compendial Notice: New Revision Markup for Reference Changes in USP–NF for details on the revision markup used to identify the reference updates.
Interested stakeholders are encouraged to alert USP staff to any impact they may recognize related to the update of those monographs.
Should you have any questions or comments, please contact Desmond Hunt, Principal Scientific Liaison (firstname.lastname@example.org), or the affected monograph’s liaisons.