BRIEFING

 European Elder Berry Dry Extract. This proposal is based on the version of the monograph official as of March 1, 2019. On the basis of comments received, the proposal published in PF 49(3) has been canceled and is being replaced with this new proposal with the following revisions:

1. Correct the footnote in the Definition to describe the meaning of the term "anthocyanosides".

2. Revise the description of the System suitability and Acceptance criteria for white light detection mode in Identification A to provide clarification about the identity of some bands.

3. Revise the description of the Acceptance criteria for 365 nm in Identification B.

4. Revise the preparations of Standard solution C and Sample solution in the test for Content of Anthocyanosides and Cyanidin.

5. Add a new caution statement in the Labeling section about allergenicity.

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

 (BDSHM: M. Monagas)

 Case ID—SUB-1627