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Monographs Affected by Revision to <1661> Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction

Type of Posting: Notice of Intent to Revise
Posting Date: 27–Dec–2019
Targeted Official Date: 1–Aug–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 a General Chapter in response to the revision of General Chapter <1661> Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction.

General Chapter <1661> was proposed for comment in Pharmacopeial Forum 45(2) and will appear in USP 43–NF 38 First Supplement. USP has identified another documentary standard that references General Chapter <1661> and thus requires revision. Therefore, <661> Plastic Packaging Systems and Their Materials of Construction will be updated in USP 43–NF 38 First Supplement along with <1661>.

All modifications will become official on August 1, 2020, to coincide with the official date of revised General Chapter <1661>.

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 (dgh@usp.org), or the affected monograph’s liaison.


CN-20-024-00