"USP functioned as FDA's proxy," Shaffer told the panel, "Doing the bidding of FDA and allowing FDA to regulate through USP while circumventing laws and due process, as well as USP's conflict of interest policies."
"No similar access was offered to other stakeholders, including my clients," Shaffer added.
Shaffer went on to state that the FDA's concerns about beyond-use dates were not rooted in science, and supported his assertion with examples, including a detailed letter from esteemed compounding educator Dr. Loyd Allen that outlined flaws in USP's approach in restricting the BUDs.
He concluded by asking the panel to remand the two chapters to the newly constituted USP Compounding Expert Committee to start anew with a mended process, including full transparency and public participation.
"The facts based on USP's own documents show that the process was as flawed as the science," said APC's Board Chair Jennifer Burch of Durham, NC, who attended the Wednesday hearing.
The hearing was the final step in USP's appeal process. The APC coalition was one of three groups that appealed of BUD restrictions in the new USP <795> and <797> chapters last fall.
The APC Coalition's appeal raised four main substantive concerns:
- Shortened BUDs are not based on science and conflict with scientifically sound information found elsewhere in USP's standards.
- The rationale for the revised BUDs is based on the premise that the previous Chapter <797> standards could not provide adequate assurance of sterility, thereby calling into question the value of the entire chapter.
- Shortened BUDs will have a profoundly negative impact on patient safety due to a lack of availability of compounded pharmaceuticals and/or treatment interruptions.
- Compounders will now face tremendous difficulties in trying to comply with the onerous, unprecedented demands imposed by the new standards, including by forcing them to produce smaller CSP and CNSP batches at a much higher cost.
