USP General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations

Free Download USP GC <795> Appeals 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

  • June 1, 2019 - Publication date of Revised <795> in USP–NF
  • September 23, 2019 - Revised General Chapter <795> is postponed until further notice. Click here for more information.

Important Note: The currently official version of General Chapter <795> (last revised in 2014) remains official until further notice.

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.

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