Where Does USP Chapter 800 Stand Following USP Appeals Panel Decision?
On March 12, 2020, an Appeals Panel of the United States Pharmacopeial Convention granted appeals to revisions of two compounding standards—General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparation , and General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. The challenges to the revisions were sent to the USP’s Compounding Expert Committee with a recommendation for “further engagement” on the issues raised in the appeals. It has since remained with the Expert Committee along with an extended Comment Period by pharmacists and compounding stakeholders.
The status of Chapters 795 and 797 is significant in terms of their effect on the applicability of USP General Chapter <800>, which governs the safe handling of hazardous drugs. Because the currently official versions of Chapters 795 (last revised in 2014) and 797 (last revised in 2008) will remain in effect until the status of the 2019 revisions is fully resolved, Chapter 800 will remain “informational and not compendially applicable.”
Under USP’s standards framework, a general chapter numbered below 1000 becomes compendially applicable and thus a required standard only when it is referenced in:
A USP monograph,
Another general chapter numbered below 1000
USP General Notices.
In the case of Chapter 800, it is referenced in the 2019 revisions of both Chapters 795 and 797, but not in the currently official versions of those chapters or in a monograph or General Notices. Accordingly, until the updates to Chapters 795 and 797 are fully resolved, Chapter 800 will remain informational and not compendially applicable.
So what does this mean for Pharmacies?
While the informational status of Chapter 800 is clear for the immediate future, it is not clear how federal and state regulators will respond and interpret. USP has made it clear that State agencies (e.g., State Boards of Pharmacy), other regulators (e.g., OSHA and FDA), and oversight organizations (e.g., The Joint Commission) may make their own determinations regarding the applicability and enforceability of Chapter 800 for organizations within their jurisdiction. USP has also stated that it continues to engage and inform regulators, accreditation organizations, and stakeholders about the compendial status of Chapter 800.
The delay, due to the revisions appeals, affords pharmacies the opportunity of time to assess how Chapter 800 affects their operations and to undertake any physical (e.g., cleanroom/lab) and operational changes dictated by that assessment.
2 Years Later… And Counting
The comment period officially closed Thursday, March 17, 2022 where pharmacists and other compounding stakeholders were able to submit comments on proposed revisions to USP Chapters <795> and <797>
Closing the comment period is a big milestone this lengthy revision process. Should there be no further delays, pharmacies can see the revisions to likely become effective sometime next year at the earliest. Which would then make USP 800 compendially applicable.
Seeking Compliance USP 800 Cleanroom Compliance?
Health Systems Pharmacies and Independent Compounding Practices have sought out ProPharma Cleanrooms to guide them towards upgrading their cleanrooms and compounding labs to meet USP 800 Standards of Compliance. Connect with a representative to get started.