Type of Posting: Notice of Intent to Revise
Posting Date: 27-Jan-2023
Targeted Official Date: 01-Sep-2023, Interim Revision Announcement
Expert Committee: Packaging and Distribution Expert Committee
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the General Chapters–Packaging and Distribution Expert Committee intends to revise General Chapter <660> Container—Glass.
USP has posted a General Announcement outlining USP’s two-prong approach to help address concerns about issues regarding the supply of glass vials, potentially threatening the availability of some existing parenteral products. Please also see the Notice of Intent to Revise: Proposal to Add Flexibility in the Selection of Suitable Packaging and Storage for Parenteral Drug Products.
The Expert Committee is proposing to revise General Chapter <660> Container—Glass, consistent with a recent FDA request to revise the Type 1 definition of glass in General Chapter <660> from one that is composition based to one that is performance based.
The request highlighted the FDA’s concern about global issues regarding glass production and resulting drug shortages. The Agency is supportive of the use of new glass compositions for parenteral products if they demonstrate suitability for the product.
It is anticipated that the revision to General Chapter <660> will be published as a Proposed Interim Revision Announcement in PF 49(2) [March-April 2023], with a comment deadline of May 31, 2023.
Should you have any questions, please contact Desmond G. Hunt, Scientific Liaison to the General Chapters–Packaging and Distribution Expert Committee (301–816–8341 or dgh@usp.org).
CN-23-025-00