Type of Posting: Notice of Intent to Revise
Posting Date: 26-Aug-2022
Targeted Official Date: TBD
Expert Committee: Small Molecules 1
In accordance with the Rules and Procedures of the Council of Experts and the Pending Monograph Guideline, this is to provide notice that the Small Molecules 1 Expert Committee intends to revise the Tobramycin Sulfate monograph.
The purpose of this revision is to widen the Acceptance criteria for the Water Determination test.
The proposed revision is expected to be posted as part of the Pending Monograph Program on November 18, 2022. The proposed revision will be published as a Revision Bulletin and an official date will be assigned to coincide as closely as possible with the FDA approval of the associated product, if such approval is granted.
See below for additional information about the proposed text.1
Should you have any questions, please contact Claire Chisolm, Senior Scientist II, 301-230-3215 or cnc@usp.org.
1 The text to be posted on November 18, 2022 will not be the official version of a USP–NF monograph and may not reflect the full and accurate contents of the official monograph as of the posting date. Please refer to the current edition of the USP–NF for official text.
USP provides this text to indicate changes that we anticipate will be made official once the product subject to this proposed revision under the Pending Monograph Program receives FDA approval. Once FDA approval is granted for the associated revision request, a Revision Bulletin will be posted that will include the changes indicated therein, as well as any changes indicated in the product’s final approval, combined with the text of the monograph as effective on the date of approval. Any revisions made to a monograph under the Pending Monograph Program that are posted without prior publication for comment in the Pharmacopeial Forum must also meet the requirements outlined in the USP Guideline on Use of Accelerated Processes for Revisions to the USP–NF.
CN-23-005-00