USP postpones new Chapter <795> and <797> effective dates
USP has informed IACP that is is postponing indefinitely the effective date of the new USP Chapters <795>, <797>, and <825>.
In a Monday, September 23 letter, USP said it was postponing the effective dates in light of the formal appeal of the chapters by IACP and its partners, as well as concerns expressed by NCPA, APhA and more than 30 state pharmacy associations, which it says will be taken into consideration at the upcoming appeal hearing.
"In light of the appeals, USP is postponing the official dates of the revised <795> and <797> and the new chapter <825>," USP wrote. "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."
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," the letter states. "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."
"We're pleased with this postponement, of course, which is the result of our formal appeal," said IACP Executive Vice President Scott Brunner, CAE. "Our input and concerns regarding the grave impacts of the new chapters' beyond-use date restrictions on patient access have been shared with USP at every step in this process - from the initial public comment period, to the conference call IACP's Board of Directors had with USP staff in July, to the August appeal hearing before the Compounding Expert Committee - and those concerns have not changed. 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."
Read USP's letter to IACP
More information about the postponements can be found