United States Pharmacopeia (USP) recently announced it is postponing the official date of three USP Chapters after receiving appeals on certain provisions in <795>, <797> and <825>. The official date of these chapters were originally scheduled for December 1, 2019. USP’s Bylaws state that the official date of a standard under appeals must be postponed while an appeal is pending. Therefore, USP is postponing the official dates for the revised <795> and <797> requirements until further notice. The 2014 version of <795> and the 2008 version of <797> will remain official. See the full announcement from USP here.
What was appealed?
In accordance with USP’s formal appeals process, stakeholders who submitted appeals on the compounding chapters have requested further review by an appointed Panel. Key topics covered in the appeals to <795> and <797> included:
- Beyond-Use Date (BUD) provisions in <795> and <797>
- Removal of Alternative Technology provision from <797>
- Applicability of <795> and <797> to veterinary practitioners
For more details of the areas of appeal, watch our latest webinar – Preparing for USP 797 Enforcement.
What about USP 800?
USP Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019, however it is considered informational and not compendially applicable during the postponement and pending resolutions of appeals of <795> and <797>.
Because the 2019 version of USP 797 and 795 reference USP 800, USP 800 has compendial applicability because it is referenced in another applicable “official” general chapter. This means that USP 800 will be informational as it is not referenced the current versions of USP 797 (2008) and USP 795 (2014). To learn more, watch this video from USP. Despite this, USP encourages utilization of the requirements laid out in USP <800> in the interest of advancing public health.
We will keep you updated as we learn more about the appeals process involving <795> and <797>, but until then we encourage you to stay the course. With enforcement of the updated chapters delayed, it's important to advance your facilities’ patient and staff safety measures while ensuring the highest level of quality.
If you are looking for any clarity on what will be enforced in your state, it is recommended that you reach out directly to your state board of pharmacy and accreditation organization to learn what they plan to enforce during the postponement.
Eric S. Kastango, MBA, RPh, FASHP of Kastango Consulting Group reminds us, “While these regulations are temporarily on hold, 797 (2008) and 795 (2014) versions will be enforced by state boards of pharmacy, the FDA and the Joint Commission. It’s so much more than about passing an inspection—it all boils down to keeping patients and staff safe. That is the priority.”