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Isotretinoin Capsules

Type of Posting: Notice of Intent to Revise
Posting Date: 27-May-2022
Targeted Official Date: 01-Jan-2023; Interim Revision Announcement
Expert Committee: Small Molecules 3

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 3 Expert Committee intends to revise the Isotretinoin Capsules monograph.

Based on the comments received with supporting data, the Expert Committee proposes to add the assay Procedure 2 to accommodate the Isotretinoin Capsules without surfactant in the formulation. Additional changes to align the monograph with current USP style are also proposed.

It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 48(4) [July- August 2022] pursuant to the Rules and Procedures. The comment period for this revision ends on September 30, 2022. In the absence of any adverse comments, the proposed IRA will become official on January 1, 2023.

Should you have any questions, please contact Jane Li, Senior Scientist II (