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USP General
Chapter <795>

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Pharmaceutical Compounding – Nonsterile

Preparations

REVISIONS TO <795> (HTTPS://GO.USP.ORG/2022_REVISIONS_795_797)  

OPEN FORUM REGISTRATION (HTTPS://WWW.USP.ORG/EVENTS-TRAINING/USP-VIRTUAL-

COMPOUNDING UPDATES (HTTPS://WWW.USP.ORG/COMPOUNDING/UPDATES)

SIGN UP FOR COMPOUNDING UPDATES (HTTPS://GO.USP.ORG/SIGN_UP_FOR_USP_COM

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
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preparations.

Important Updates

November 1, 2022 – Register for Open Forums for <795>

(https://www.usp.org/events-training/usp-virtual-open-forum-series-
revisions-to-compounding-general-chapters)

Feedback
November 1, 2022 – Revisions to USP General Chapters <795> and
<797> (https://go.usp.org/2022_Revisions_795_797)
May 14, 2022 – Compounding Expert Committee Update on <795> and
<797> (https://www.usp.org/sites/default/files/usp/document/our-
work/compounding/usp22-hqs-compounding-update document-v1.pdf)

Important Note: The currently official version of General Chapter <795> (last

revised in 2014) remains official.

For information on other compounding chapters click here

(https://www.usp.org/healthcare-quality-safety).

Previous Important <795> Updates

(https://www.usp.org/compounding/previous-important-795-updates)

 
Developing USP General Chapter <795>
USP is a not-for-profit, science-driven organization that has an established process
(/sites/default/files/usp/document/health-quality-safety/healthcare-safety-
standard-setting-process-2018.pdf) 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
(http://www.usp.org/expert-committees/compounding-expert-committee-work-
plan).
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Stay Involved: Stakeholder Engagement
Your participation is integral to the standard setting process. Stay involved and sign
up to receive updates (/hqs-signup-form) from USP.

Resources
USP <795> FAQs (https://go.usp.org/USP_GC_795_FAQs)
USP <795> Commentary

Feedback
(https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-nf-
commentary/795-commentary-20221101.pdf)
USP General Chapter Education Courses
(https://uspharmacopeia.csod.com/LMS/catalog/Welcome.aspx?
tab_page_id=-67)
Sign up for USP Compounding Updates
(https://go.usp.org/Sign_Up_for_USP_Compounding_Updates)

Explore compounding
education, digital resources and
clinical support tools

Compounding Compendium
Access 200+ compounding-related standards

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 ACCESS NOW (HTTPS://WWW.USP.ORG/PRODUCTS/USP-COMPOUNDING-COMPENDIU

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HazRx®
Know your exposure and download the HazRx® Mobile App

(https://itunes.apple.com/us/app/800-

hazrx/id1287841111?ls=1&mt=8)   

(https://play.google.com/store/apps/details?id=org.usp.android.HazrxApp)

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 Feedback
USP Education
USP Education Compounding Week, November 15-17

GET YOUR DISCOUNT NOW (HTTPS://USPHARMACOPEIA.CSOD.COM/DEFAULT.ASPX?P

Also of Interest
USP compounding standards (https://www.usp.org/compounding)
Recognition of USP Compounding Standards (https://www.usp.org/compounding/legal-
considerations)
USP Compounding Compendium (https://www.usp.org/products/usp-compounding-compendium)

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