The voice for compounding pharmacy  |  November 26, 2019
USP <795> and <797> appeals hearings set for January
IACP and its fellow appellants have agreed to USP's suggested January 21-22 hearing dates on our appeal of beyond-use-date restrictions in the new <795> and <797> chapters. After the initial appeal by IACP, Innovation Compounding and Wedgewood was denied by the USP Compounding Expert Committee in August, we requested an appeal hearing as provided for in the USP bylaws. At the January 21-22, IACP and its partners will be allowed two hours to present to an appeals panel selected, USP says, to include relevant scientific and USP process expertise. The appellants may present both process and scientific arguments relevant to the BUD restrictions in the new chapters. In light of the appeals, USP in September indefinitely postponed enforcement of the new chapters.
  1. IACP's initial reporting on the BUD date restrictions in <795> and <797>
  2. IACP's Appeal (with Wedgewood and Innovations Compounding)
  3. USP Compounding Expert Committee's notification of rejection of the appeal
  4. IACP's (and partners') request for hearing on the appeal
  5. USP's announcement of indefinite postponement of the chapters
  6. IACP's briefing paper for members and state boards of pharmacy
  7. IACP's CALL TO ACTION to members to urge state BOPs to express concerns to USP
  8. USP's November 4 FAQ on Compounding Appeals