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.
- November 1, 2023 – USP General Chapter <795> Becomes Official
- November 8, 2022 – Overview of Open Forum for <795>
- November 1, 2022 – Revisions to USP General Chapters <795> and <797>
Important Note: USP General Chapter <795> can be accessed via a subscription to the USP Compounding Compendium or USP-NF
Click here for previous important <795> updates.
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.