When should my facility submit the application for our facility to be inspected based on the proposed, revised compounding USP Chapters?
VPP applications received June 1– September 31, 2023:
- USP <795> – Can be inspected to 2014 standards or 2023 standards.*
- USP <797> – Can be inspected to 2008 standards or 2023 standards.*
- USP <800> – Will be inspected to 2019 standards.
VPP applications received on October 1, 2023 or after:
- USP <795> – Will be inspected to 2023 standards.
- USP <797> – Will be inspected to 2023 standards.
- USP <800> – Will be inspected to 2019 standards.
- USP <825> – Will be inspected to 2023 standards.
*Based on the application date and if your facility places your application on a 1 time hold for 6 months for $500, it could cause your facility to be inspected from the 2023 standards.
Note
For applications submitted on or after September 1, 2023, there is not a guarantee that the inspection will be completed before the proposed, revised USP compounding chapters are in effect. Any inspection that occurs on or after November 1, 2023 will be inspected on the 2019 standards for USP <800> or 2023 standards for USP <795> and USP <797>.
Visit the USP website for the latest USP updates and information.