Type of Posting: Notice of Intent to Revise
Posting Date: 31– May –2019
Targeted Official Date: 01–Dec–2020, USP 43-NF 37, Second Supplement
Expert Committee: Chemical Medicines Monographs 5
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 5 Expert Committee intends to revise the Dydrogesterone monograph.
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. Monographs may also be proposed for omission to address safety concerns. Based on evaluation of the monograph, the USP Chemical Medicines Monographs 5 Expert Committee has determined that the Dydrogesterone monograph should be proposed for omission in the Pharmacopeial Forum (PF).
USP Dydrogesterone RS, associated with this monograph, is currently unavailable. USP does not intend to develop a replacement lot for USP Dydrogesterone RS in anticipation of the omission of this monograph.
It is anticipated that the proposed revision will be published in PF 45(5) [Sep.–Oct. 2019].
Should you have any questions, please contact Morgan Puderbaugh, Senior Scientific Liaison (301–816–8373 or mxp@usp.org).
CN-19-041-00