United States Pharmacopeia published the revised <795> and <797> chapters November 1, 2022. These chapters become official November 1, 2023.
Revisions to the chapters can be accessed through a subscription to the USP Compounding Compendium. The subscription provides access to:
- USP <795> and USP <797> and 40+ compounding related General Chapters
- 70+ compounding monographs from the United States Pharmacopeia and the National Formulary (USPNF)
- Continuous online access to the most up-to-date published version of the compounding compendium
- Compendial notifications to alert subscribers of newly released and/or updated content
On November 8, 2022, USP Compounding Executive Committee held an Open Forum on the 2022 revisions to General Chapters <795> and <797>:
In addition, the USP Compounding Executive Committee put together an extensive list of Frequently Asked Questions for the chapters:
When the revisions to USP <795> and <797>, which contain references to USP <800>, become official on November 1, 2023, <800> will be required and compendially applicable only to the extent to which USP General Chapters <795> and <797> apply.
Compounders are encouraged to check with state agencies (state boards of pharmacy), other regulators (Occupational Safety and Health Administration), and oversight organizations as these agencies may make their own determination regarding the applicability and enforceability of USP <800>.
The time to prepare is now for the chapter revisions. ARL published newsletters in June-September 2022 highlighting proposed chapter updates:
- Personnel Qualification and Environmental Monitoring Requirements for Compounded Sterile Preparations (CSPs) Categories 1 and 2
- Personnel Qualification and Environmental Monitoring Requirements for Compounded Sterile Preparations (CSPs) for Category 3
- Release Inspections and Testing for Categories 2 and 3
- Beyond Use Dating
Save the Date: USP will host a compounding workshop on February 7 – 8, 2023. The workshop will have options for both virtual and in-person attendance at the USP headquarters in Rockville, MD.