Extended Public Comment Period of Proposed Revisions to USP Compounding General Chapters
Wednesday, September 1, 2021: The United States Pharmacopeia (USP) announced the following Compounding General Chapters are available to an extended public comment period until January 31, 2022
<795> Pharmaceutical Compounding – Nonsterile Preparations
<797> Pharmaceutical Compounding – Sterile Preparations
USP Stated: “Revisions to chapters <795> and <797> reflect public health considerations, scientifically robust approaches, and numerous stakeholder engagement activities. The Compounding Expert Committee (CMP EC) engaged healthcare practitioners, regulators, academicians, and other key stakeholders in various sessions including semi-structured interviews with stakeholders, a small roundtable discussion with invited participants, and a broader open forum discussion to collect feedback from a broad range of stakeholders. These engagements helped the CMP EC consider a wide range of perspectives to inform the revisions while maintaining scientific rigor and accounting for today’s public health and practice needs.”
Open Forum Sessions are scheduled as follows:
<795> Sessions
September 8, 2021, 1:00 p.m. – 3:00 p.m. ET
January 12, 2022, 10:00 a.m. – 12:00 p.m. ET
<797> Sessions
September 15, 2021, 2:00 p.m. – 4:00 p.m. ET
January 19, 2022, 10:00 a.m. – 12:00 p.m. ET
During each session, members of the CMP EC will highlight the proposed revisions to USP General Chapters <795> and <797> and briefly provide the rationale for the requirements and recommendations in the proposed revisions. Participants will have an opportunity to pose questions on the proposed revisions from the members of the CMP EC.
Sessions will be recorded and uploaded to the USP website for on-demand viewing. To facilitate dialogue, the CMP EC is offering pre-read materials for attendees. Participants in the open forums are strongly encouraged to download and review those documents before each session.
To register to participate in the sessions, please click event links below: