Type of Posting: Notice of Intent to Revise
Posting Date: 31–May–2019
Targeted Official Date: December 1, 2020, USP-NF
Expert Committee: Packaging and Distribution Expert Committee
In accordance with section 7.04(c) of the 2015–2020 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:
- <381> Elastomeric Closures for Injections
- <382> Elastomeric Component Functional Suitability in Parenteral Products Packaging /Delivery Systems
- <1381> Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems
- <1382> Assessment of Elastomeric Component Functional Suitability in Parenteral Products Packaging /Delivery Systems
The proposed revisions are posted below and will be published as an In Process Revision (IPR) in Pharmacopeial Forum 45(4) [Jul.–Aug. 2019]. The objective of this pre-posting is to give stakeholders ample time to review chapters and comment by the September 30, 2019 deadline. In the absence of any adverse comments the proposed IPR is anticipated to publish in USP 43-NF 38, Second Supplement.
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-19-040-00