BRIEFING

 Powdered Feverfew. This proposal is based on the version of the monograph official as of December 1, 2015. The proposal published in PF 47(6) has been canceled and is being replaced with a new proposal with the following revisions:

1. Update the monograph title to Feverfew Leaf Powder.

2. Add a minimum content requirement for parthenolide in the Definition.

3. Replace the TLC procedures in Identification B and Identification C with HPTLC procedures for parthenolide and flavonoids and relabel them as Identification A and B, respectively.

4. Relabel the original Identification A as Identification C.

5. Add a new caution label statement in the Labeling section: "Dosage forms prepared with this article should bear the following statement: 'Feverfew and extracts derived from it may cause infrequent allergic reactions, rashes, or aggravate asthma, especially in those who are allergic to plants of the daisy family.'"

6. Add USP Apigenin RS, USP Apigenin-7-glucoside RS, and USP Chrysanthemum × morifolium Flower Dry Extract RS to the USP Reference Standards section, and withdraw USP Rutin RS.

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

 A new table format for presenting HPTLC test results is being introduced to Identification A and B to describe their System suitability and Acceptance criteria requirements. USP welcomes feedback from stakeholders about the proposal of this new format.

 (BDSHM: M. Monagas)

 Case ID—SUB-216