USP General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations

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:
The General Chapter was last revised in its entirety in USP 34–NF 29, which became official on May 1, 2011. A Revision Bulletin was issued on Nov. 22, 2013, with an official date of Jan. 1, 2014, to clarify that the maximum beyond-use dates in the chapter may be applied only to nonsterile preparations.
A future revision to General Chapter <795> will be proposed in the Pharmacopeial Forum for public comment to harmonize with USP General Chapter <800>.
Important Dates
- TBD: Revision proposed in the Pharmacopeial Forum for public comment
While General Chapter <795> is undergoing revision, the published version of the chapter which became official on Jan 1, 2014 is currently 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.