USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.
The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs.
USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.
- February 1, 2016 – Publication Date of General Chapter <800>
- May 31, 2019: Revision Bulletin published to confirm the official date of USP General Chapter <800>
- December 1, 2019: Official date for General Chapter <800>
Note: The revised General Chapters <795> and <797> have been postponed until further notice. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable.
For more information on other compounding chapters click here.
To protect patients and healthcare workers from potential harm, USP General Chapters <800> Hazardous Drugs – Handling in Healthcare Settings <797> Pharmaceutical Compounding – Sterile Preparations and <795> Pharmaceutical Compounding – Nonsterile Preparations were developed to provide a complete set of standards for all healthcare workers to help ensure the safe handling of hazardous drugs throughout the healthcare system, including in the practice of compounding. The intent of the Expert Committee has always been to align these standards, providing a unified approach to quality compounding.
Developing USP General Chapter <800>
Public Health Need
The need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. Growing evidence highlights that acute and chronic health effects can occur due to occupational exposure to over 200 hazardous drugs used commonly in healthcare settings. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. The goals of these standards are to help increase awareness, provide uniform guidance to reduce the risk of managing hazardous drugs, and help reduce the risk posed to patients and the healthcare workforce.
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 standard-setting progress.
The USP Compounding Expert Committee is responsible for the development of General Chapter <800>. Review their work plan and past meeting summaries. General Chapter <800> was published on February 1, 2016.
- USP <800> FAQs
- USP <800> Commentary
- Summary of updates of revised (postponed) chapter (published 07/03/2019)
- BUD Fact Sheet for revised (postponed) General Chapters <795> & <797> (published 07/03/2019)
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