Type of Posting: Notice of Intent to Revise
Posting Date: 23–October–2020
Targeted Official Date: 01–August–2022, USP–NF 2022 Issue 2
Expert Committee: Small Molecules 2
In accordance with section 9.04(c) of the 2020–2025 Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to omit the Methyldopate Hydrochloride and Methyldopate Hydrochloride Injection monographs.
USP may propose to omit a monograph from the USP–NF if the article is no longer marketed in the United States and where the monograph is not necessary to serve a public health need. Based on evaluation of the monographs, the Small Molecules 2 Expert Committee has determined that the Methyldopate Hydrochloride and Methyldopate Hydrochloride Injection monographs should be proposed for omission in the Pharmacopeial Forum (PF).
USP Methyldopate Hydrochloride RS, associated with these monographs, is currently unavailable. USP does not intend to develop a replacement lot for USP Methyldopate Hydrochloride RS in anticipation of the omission of these monographs.
It is anticipated that the proposed revisions will be published in PF 47(2) [Mar.-Apr. 2021].
Should you have any questions, please contact Morgan Puderbaugh, Senior Scientific Liaison (301–816–8373 or mxp@usp.org).
CN-21-024-00