Proposed revisions to <795> Open Forum Registration Compounding Updates
Millions of medications are compounded each year in the US to meet the unique needs of patient, including vulnerable populations such as seniors and children. Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases.
Compounded medications made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death.
USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter <795> provides standards for compounding quality nonsterile preparations.
Important Updates
- September 1, 2021 – Proposed revisions to <795> and <797>
- September 1, 2021 – Registration for Open Forums for proposed revisions to USP General Chapters <795> and <797>
- November 25, 2020 - USP Stakeholder Engagement on veterinary compounding (General Chapters <795> & <797>)
- September 15, 2020 - Open Forum for Beyond-Use Date (BUD) Provisions in General Chapters <795> & <797>
- July 21, 2020 - USP Stakeholder Engagement Plan on Beyond-Use Date (BUD) Provisions in General Chapters <795> & <797>
- Registration opened for September 15, 2020 Open Forum
- May 26, 2020 – Update on stakeholder engagement activities related to beyond-use-date (BUD) provisions in General Chapters <795> & <797>
- March 12, 2020 – Appeals Panel issues decisions on the Appeals to USP <795>, <797>, and <825> (see FAQs on USP Compounding Appeals)
- September 23, 2019 - Revised General Chapter <795> is postponed until further notice. Click here for more information.
- June 1, 2019 - Publication date of Revised <795> in USP–NF
Important Note: The currently official version of General Chapter <795> (last revised in 2014) remains official.
For information on other compounding chapters click here.
Developing USP General Chapter <795>
USP is a not-for-profit, science-driven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard setting process.
The USP Compounding Expert Committee is responsible for the development of General Chapter <795>. Review their work plan and past meeting summaries.
Stay Involved: Stakeholder Engagement
Your participation is integral to the standard setting process. Stay involved and sign up to receive updates from USP.
Resources
- USP <795> FAQs
- Decisions on Appeals to USP <795>, <797>, and <825> (published 03/12/2020)
- Expert Committee Decisions on Appeals General Chapters <795> & <797> (published 08/16/2019)
- FAQs on USP Compounding Appeals
- USP General Chapter Education Courses
- Sign up for USP Healthcare Quality & Safety Updates
