Type of Posting: Notice of Intent to Revise
Posting Date: 25–Feb–2022
Targeted Official Date: 01–May–2026, Revision Bulletin
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 〈665〉 Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products.
As currently published, there are no requirements that are mandatory for compendial compliance purposes in this chapter. General Notices 3.10, Applicability of Standards states that a chapter below 〈1000〉 does not become an applicable general chapter unless referenced as such in General Notices, a monograph, or another applicable general chapter numbered below 〈1000〉. As none of these situations currently applies to 〈665〉, it is not an applicable general chapter. However, there have been inquiries around the applicability of the chapter and the current official date of May 1, 2022. To address these inquires and to give USP time to engage stakeholders regarding the advisability of making 〈665〉 an applicable general chapter and track the ICH Q3E development effort, USP intends to extend the official date for 〈665〉 to May 1, 2026.
It is anticipated that the revision will be posted as a Revision Bulletin April 29, 2022.
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-22-037-00