BRIEFING

 Clonidine Transdermal System. This proposal is based on the version of the monograph official as of December 1, 2021. On the basis of comments received it is proposed to:

1. Delete the test for Organic Impurities to address the urgent regulatory concerns regarding acceptance criteria for Organic Impurities. For more information about this, please see the USP Compendial Notice "Clonidine Transdermal Systems: Removal of Test for Organic Impurities". Stakeholders are encouraged to submit comments for the Expert Committee's consideration.

2. Add a Note in the Assay providing clarification and additional flexibility to the Sample solution preparation for drug products with USP Drug Release test other than Test 1.

 Additionally, other updates are proposed to:

1. Correct the reagent name of the diluted hydrochloric acid in Identification A.

2. Correct the reagent sodium acetate monohydrate to sodium acetate (trihydrate) in Drug Release Test 3 based on original validation data.

3. Update the molecular weight of USP Clonidine Related Compound B RS in the USP Reference Standards section.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 The comment period for this revision ends on March 31, 2024. In the absence of any significant adverse comments, it is proposed to implement this revision via an Interim Revision Announcement with an official date of July 1, 2024.

 (SM2: S. Shane)

 Correspondence Number—C316202