USP General Chapter 797

Proposed revisions to <797> Open Forum Registration Compounding Updates

Millions of medications are compounded each year in the US to meet the unique needs of patients. Compounding provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Medications that are required to be sterile include those administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine).

Understanding the risks inherent in sterile compounding and incorporating established standards are essential for patient safety. 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 preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing.

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 <797> is postponed until further notice. Click here for more information.
June 1, 2019 – Publication Date of Revised <797> in USP–NF

*IMPORTANT NOTE: The currently official version of General Chapter <797> (last revised in 2008) remains official.

For more information on other compounding chapters click here.

Developing USP General Chapter <797>

USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in 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 standards’ progress.

The USP Compounding Expert Committee is responsible for the development of General Chapter <797>. Review their work plan and past meeting summaries.