USP Draft Chapters for Glass and Plastic Packaging Systems

Recommendation

6/7 June 2023

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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.

<660> Containers - Glass

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".

<661.2> Plastic Packaging Systems for Pharmaceutical Use

The General Chapters—PDEC is proposing the following changes:

• Physicochemical Tests: Revision of the extraction time and temperature to address the concern that some plastic packaging materials start to melt and deform at the temperatures currently outlined in the chapter. Thus, the revision includes an additional extraction time and temperature of 50 ± 2° for 72 h.
• Total Organic Carbon (TOC): Revision of the acceptance criteria to align with that in USP´s TOC Chapter <643>, which was revised in 2021.

The proposed USP General Chapters <660> and <661.2> are available after registration to the Pharmacopeial Forum.