The United States Pharmacopeia (USP) is indefinitely postponing the effective date of three controversial USP chapters after several pharmacy groups appealed the guidelines.
Earlier this year, the International Academy of Compounding Pharmacists, NCPA, APhA, and more than 30 state pharmacy associations appealed USP chapters <795> and <797> and the new chapter <825>.
"We're pleased with this postponement, of course, which is the result of our formal appeal," says Scott Brunner, executive vice president of IACP, in a statement. "Our input and concerns regarding the grave impacts of the new chapters' beyond-use date [BUD] restrictions on patient access have been shared with USP at every step in this process…We hope this postponement is an indication that USP will work with IACP and our partners to find solutions that assure both patient safety and patient access.”
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USP “failed to address the lack of scientific basis for the BUD restrictions,” Brunner said on IACP’s web site in August.
The chapters, which were set to go into effect on December 1st, will now be postponed “until further notice”, USP said in a notice on its web site.
In the interim, the currently official chapters of <795> (last revised in 2014) and <797> (last revised in 2008) including the section Radiopharmaceuticals as CSPs will remain official, USP said.
The postponement does not affect the effective date of USP <800>. "General Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019," USP said. "During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable. USP encourages utilization of USP <800> in the interest of advancing public health.”