General Chapter <797> Pharmaceutical Compounding – Sterile Preparations

Millions of medications are compounded each year in the US to meet the unique needs of patients. Compounding provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Medications that are required to be sterile include those administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine).

Understanding the risks inherent in sterile compounding and incorporating established standards are essential for patient safety. 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 preparing compounded sterile drugs to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing.

USP General Chapter <797>  describes a number of requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring, and storage and testing of finished preparations.

Important Updates
The next revision to General Chapter <797> is anticipated to be published in the Pharmacopeial Forum 44(5) September/October 2018 for a second round of public comment and is expected to become official on December 1, 2019.
The official date for the revised <797> will be harmonized with USP General Chapter <800>. Sections of the revised <797> may have longer implementation dates that will allow time for implementation.
Important Dates:
- September 4, 2018: Revision proposed in the Pharmacopeial Forum 44(5) for second round of public comment
- December 1, 2019: Revised USP General Chapter <797> expected official date
Until the revision process is completed, the currently published version of the USP <797> chapter, which became official on June 1, 2008, is the official standard.


Developing USP General Chapter <797>

USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in 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 standards’ progress.

The USP Compounding Expert Committee is responsible for the development of General Chapter <797>. Review their work plan and past meeting summaries. General Chapter <797> is currently in an active revision process.

A revision to General Chapter <797> was proposed for public comment from Sept. 25, 2015 to Jan. 31, 2016, and remains in the development process with the Expert Committee. The chapter is anticipated to go through a second round of public comment September 2018, after draft publication in the Pharmacopeial Forum 44(5).

Public comment is integral to the standard setting process. During standard development, public comment is designed to obtain input from stakeholders such as patients, healthcare practitioners, policymakers, academicians, and industry to ensure that broad perspectives are included in the standard.

Note: While General Chapter <797> is undergoing revision, the published version of the chapter which became official on June 1, 2008 is currently official.

Stay Involved: Stakeholder Engagement

Learn more about the second posting for public comment and sign up to the Healthcare Quality Standards Newsletter Healthcare Quality Standards Newsletter to receive updates on the chapter revision.