Comment Period Extended for USP Packaging General Chapters Appearing in PF 43(3)

Recommendation

7/8 May 2024

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On July 21, 2017, the United States Pharmacopeia (USP) informed about important announcements related to the USP-NF:

On the basis of comments received, the USP is extending the comment deadline for the PF 43(3) revision proposal. So far the deadline was July 31, 2017 and has now been extended for the following Packaging (and Materials) General Chapters by 60 days to September 30, 2017:

•  <381> Elastomeric Components Used in Injectable Pharmaceutical Packaging/Delivery Systems (Revision)
• <1381> Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems (New)
• <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems (New)
• <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems (New)
  
  
•  <660> Glass Containers Used in Pharmaceutical Packaging/Delivery Systems - (minor Revision - major revisions coming in 2018!)
•  <1660> Glass Containers Used in Pharmaceutical Packaging/Delivery Systems: Manufacture and Evaluation of the Inner Surface Durability (Revision)
  
  
• <665> Polymeric Components and Systems Used in in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products  (New)
• <1665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products  (New)

Please note: The new general chapters <665> and <1665> address the qualification of polymeric components used in the manufacture of both pharmaceutical and biopharmaceutical active pharmaceutical ingredients (APIs) and drug products (DPs). Similar to the revised chapter <381> the draft of new general chapter <665> contains a section on Extractable Metals (Extractable Elements) and sections on Biological Reactivity.

USP says "the purpose of this extension is to allow interested stakeholders ample time to evaluate the proposed changes and submit comments to USP. Please note that when a commenter attempts to send comments or questions through PF, a pop-up notice will appear stating that the comment period has closed for PF 43(3). Please disregard this statement and select "OK" in the pop-up box to continue submitting comments or questions."

For further information please visit the USP General Announcements website.