USP Delaying Revisions to <795> & <797>
The United States Pharmacopeia announced this week that the revisions to USP <795> (non-sterile compounding) and USP <797> (sterile compounding) published June 1, 2019, will be delayed. The updates to the two chapters were originally scheduled to take effect on December 1, 2019, but pending appeals require further review according to USP bylaws.
What appeals to <795> and <797> will the USP continue to review?
- Beyond Use Date (BUD) provisions
- Applicability to veterinary practitioners
- Alternative Technology provision in <797>
Read more about the USP's most recent decision on these appeals >
USP <800> will still take effect as of December 1, 2019. Compounding pharmacies that handle chemicals found on the NIOSH hazardous drugs list will need to continue with any renovations and changes to SOPs (standard operating procedures) that they began or have already completed in preparation for changes to guidelines for handling hazardous drugs.
While the USP says that they consider Chapter <800> informational only and not compendially applicable until the revisions to <797> are resolved, they include an important disclaimer that federal and state regulators will make their own decisions regarding enforcement.
Is your facility ready for USP <800>? Do you have any questions about complying with revised USP chapters?
Let us help: start by giving us a call at 877.LETCORX to talk to our Compounding Support Services team of experts.
Need more robust regulatory consulting?
Letco customers can get special pricing on services including readiness assessment, staff training, customizable SOP libraries, and more through our Regulatory Solutions Program.
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