Type of Posting: Notice of Intent to Revise
Posting Date: 26–Apr–2019
Targeted Official Date: TBD
Expert Committee: Monographs-Chemical Medicines 2
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 Chemical Medicines Monographs 2 Expert Committee intends to revise the Fentanyl monograph.
Proposed revisions to the Fentanyl monograph were published for public notice and comment in Pharmacopeial Forum 44(1) [Jan.–Mar. 2018]. The proposed Organic Impurities test is intended to replace the one which is postponed in the currently official Fentanyl monograph. In the interim, USP wishes to clarify that the postponed Organic Impurities test in the currently official USP Fentanyl monograph does not need to be performed to demonstrate conformance to monograph specifications.
The comment period for the PF 44(1) revision proposal ended on March 31, 2018. The Chemical Medicines Monographs 2 Expert Committee is currently evaluating the comments received and planning for a future ballot. The ballot results will be published on our website (https://www.uspnf.com/official-text/proposal-statuscommentary).
Should you have any questions, please contact Wei Yang, Scientific Liaison to the Chemical Medicines Monograph 2 Expert Committee at (301–816–8338 or wiy@usp.org).
CN-19-036-00