Type of Posting: Notice of Intent to Revise
Posting Date: 24–April–2020
Targeted Official Date: 01–Dec–2021, USP–NF 2021, Issue 3
Expert Committee: Biologics Monograph 3- Complex Biologics
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 Biologics Monograph 3- Complex Biologics Expert Committee intends to omit the Aprotinin and Aprotinin Injection monographs.
Aprotinin injection is no longer marketed in the U.S. and the Aprotinin Reference Standard (RS) is not available for purchase from USP. Additionally, USP plans to discontinue the USP Crystallized Trypsin RS which is referenced in the Aprotinin and Aprotinin Injection monographs. It is anticipated that the proposals to omit these monographs will be published in PF 46(5) [Sep- Oct.. 2020].
Should you have any questions, please contact Shyamosree Bhattacharya, Associate Science and Standards Liaison (firstname.lastname@example.org).