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 drugs 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 drugs 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. The chapter describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. General Chapter <795> also provides general guidelines for assigning beyond-use dates to nonsterile preparations.
Important Updates
- March 30, 2018 - The proposed revision to <795> was posted for public comment*
- April 20, 2018 - Open Microphone Session - Recorded Session
- May 1, 2018 - <795> was formally published in the Pharmacopeial Forum (PF) 44(3) [May.-Jun. 2018]
- July 31, 2018 - Public Comment Period for <795> closed
- June 1, 2019 - Intended Publication Date of <795> in USP–NF
- December 1, 2019 - Anticipated Official Date for <795>
* The current published version of General Chapter <795> in USP-NF is official until the new Chapter becomes official.
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. General Chapter <795> is currently under review and being considered for revision.
Stay Involved: Stakeholder Engagement
Stay involved and sign up to the Healthcare Quality Standards Newsletter to receive updates on the chapter revision and opportunity for public comment.
Public comment is integral to the standard setting process. During standard development, USP seeks to obtain input from stakeholders such as patients, healthcare practitioners, policymakers, academicians, and industry, to ensure that broad perspectives are included in the standard.
Resources
- USP General Chapter <795> FAQ
- Strength and stability testing for compounded preparations
- USP General Chapter <795> Education Courses
- Sign up for USP Updates
