Many in the pharmacy industry welcome news that the United States Pharmacopeia (USP) plans to publish revised standards for USP General Chapters <795> and <797> on November 1, 2022. The announcement comes more than three years after USP first published proposed revisions in 2019.

USP <795> and <797> provide standards for preparing sterile and nonsterile compounded medications. Revisions will expand quality and safety measures to minimize risk for patients and pharmacy personnel. The revisions will also address enforcement to USP Chapter <800>, which focuses on the safe handling of hazardous drugs.

Background

Delays and updates have extended the revision process from the start.

Appeals from industry stakeholders initially kept the proposed revisions on hold. After additional review, USP published updated versions of the proposed revisions on September 1, 2021. Actions on the measures were delayed even further when USP pushed the comment period beyond the January 31, 2022, deadline through March 17, 2022.

What It Means to You

Accreditation Commission for Health Care (ACHC) considers the revisions to be final versions and does not expect an additional comment period. No information has been provided yet on an implementation time frame. We will keep you updated as we receive more information from USP.

ACHC plans to revise standards for Compounding Pharmacy (PCAB) and Infusion Pharmacy Accreditation as we learn more and will keep you informed of timelines for compliance.

Updated tools and resources also will be available from ACHCU, the education division of ACHC.