Type of Posting: General Announcement
Posting Date: 28–Jul–2017
Expert Committee: General Chapters—Packaging and Distribution
On the basis of comments received to date, USP is extending the comment deadline for the Pharmacopeial Forum (PF) 43(3) revision proposal for the following General Chapters by 60 days to September 30, 2017:
- <381> Elastomeric Components Used in Injectable Pharmaceutical Packaging/Delivery Systems
- <1381> Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems
- <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems
- <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems
- <660> Glass Containers Used in Pharmaceutical Packaging/Delivery Systems – major revisions coming in 2018
- <1660> Glass Containers Used in Pharmaceutical Packaging/Delivery Systems: Manufacture and Evaluation of the Inner Surface Durability
- <665> Polymeric Components and Systems Used in in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products
- <1665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products
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.
Please contact Desmond Hunt, Ph.D. at firstname.lastname@example.org or 301-816-8341 if you have any questions.