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News & Press: Breaking News

The USP appeal: Everything you need to know

Friday, October 4, 2019  
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As you know - at least, we hope you know - USP in August rejected three appeals by compounding pharmacy groups, including one to which IACP was a party, regarding beyond-use date restrictions in the new <795> and <797> chapters. As a result, IACP and its partners have formally requested a hearing by a USP panel whose appointees are outlined in the USP Bylaws. USP has not yet set a hearing date, but announced recently that it has postponed the effective date of chapters <795>, <797> and <825> indefinitely as a result of BUD-date appeals.
For now, here are quick links to documents and other info about the appeal and USP's postponement:
  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

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