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USP grants appeals, remands chapters for "further engagement"
A USP Appeals Panel's has granted appeals by APC and two other groups related to beyond-use date restrictions in the new <795> and <797> chapters and has remanded the chapters to USP's Compounding Expert Committee.
In a March 11 letter to the attorney for the Alliance for Pharmacy Compounding and its co-appellants Wedgewood Pharmacy and Innovations Compounding, USP President Jesse Goodman makes clear that the Appeals Panel did not "conclude that the chapters require modification; rather ... that their finalization warrants additional dialogue about, and consideration of, issues raised in the appeals."
The letter continues:
For the foregoing reasons, this Appeals Panel grants your appeals and remands
General Chapters <795> and <797> to the Compounding Expert Committee with the
recommendation for further engagement with regards to the issues you have raised.
We note that most aspects of the Chapters have broad support and that the intent of
the Chapters is to protect public health and patient safety. In this spirit, we will
encourage USP and the Compounding Expert Committee to move forward in an
open, transparent, and balanced manner as soon as practicable to enable the public health benefits these standards are intended to address.
"We're grateful to the Appeals Panel for hearing us and taking seriously the concerns we've raised, both about the scientific validity of beyond-use date restrictions in the new chapters as well as a process that privileged FDA input above that of other stakeholders," said APC Board Chair Jennifer Burch of Durham, NC. "This is a good decision for patients who use compounded medications. We look forward to engaging with the new Compounding Expert Committee to make our case on the BUD restrictions."
"This is a great win for continued patient access to pharmacy compounding," added APC President Shawn Hodges. "Our concerns will be truly heard via a renewed process that USP promises will be open, transparent and balanced. I thank the USP Appeals Panel for carefully reviewing and acknowledging our concerns."
Until this matter is settled, the current General Chapters <795> and <797> (last updated in 2008) remain in effect.
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