Skip to main content

Monographs and General Chapters Affected by Omission of <1045> Biotechnology Derived Articles

Type of Posting: Notice of Intent to Revise

Posting Date: 31–Jul–2015

Targeted Official Date: 01–May–2016

Expert Committee: Various

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple General Chapters in response to the omission of General Chapter <1045> Biotechnology Derived Articles.

General Chapter <1045> was proposed for comment in Pharmacopeial Forum 40(5) and will appear in USP 39–NF 34 with an official date of May 1, 2016. The references to General Chapter <1045> Biotechnology Derived Articles will be removed from the following General Chapters:

  • <92> Growth Factors and Cytokines Used In Cell Therapy Manufacturing
  • <787> Subvisible Particulate Matter in Therapeutic Protein Injections
  • <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
  • <1059> Excipient Performance

All modifications will become official on May 1, 2016 to coincide with the omission of General Chapter <1045>.

Please also see the Compendial Notice: New Revision Markup for Reference Changes in USP–NF for details on the revision markup used to identify the reference updates.

Interested stakeholders are encouraged to alert USP staff to any other effects they may recognize related to the revision of General Chapter <1045>.

Should you have any questions or comments, please contact Maura Kibbey, Senior Scientific Liaison (301-230-6309 or mck@usp.org).