6/7 June 2023
The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum PF 49(2). The deadline for comments is May 31, 2023.
As previously announced in USP´s Notice of Intent to Revise, the General Chapters—Packaging and Distribution Expert Committee (PDEC) is proposing to revise its general chapter <660> to address a recent FDA request to update the Type I definition from one that is composition-based to performance-based (e.g. hydrolytic resistance). 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 that are not currently outlined in the USP if they demonstrate equivalency or superior performance to Type I borosilicate glass. According to the proposal´s briefing, "the current USP definition is impeding the adoption of new glass compositions and delaying drug approvals".
The General Chapters—PDEC is proposing the following changes:
The proposed USP General Chapters <660> and <661.2> are available after registration to the Pharmacopeial Forum.