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.
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.
USP is announcing the intent to postpone the official date of General Chapter <800>. The purpose of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceutical Compounding — Sterile Preparations, to provide a unified approach to quality compounding.
- September 29, 2017: Notification of intent to revise the official date of USP General Chapter <800>
- December 1, 2019: USP General Chapter <800> expected official date
To protect patients and healthcare workers from potential harm, USP General Chapters <800> Hazardous Drugs – Handling in Healthcare Settings and <797> Pharmaceutical Compounding – Sterile 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. 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. Both USP General Chapter <797> and USP General Chapter <800> are anticipated to become official on December 1, 2019. Sections of the revised <797> may have longer implementation dates that will allow time for adoption of the standard.
As we all move towards safer handling of hazardous drugs in the work place, USP strongly encourages early adoption and implementation of USP General Chapter <800> to protect the public health in all healthcare settings. We will continue to support our stakeholders through ongoing education and outreach.
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. USP General Chapter <800> was published twice in the Pharmacopeial Forum for public comment. USP received over 1,300 comments from approximately 150 stakeholders during the second public comment period (Dec. 1, 2014, to May 31, 2015). All of the public comments were reviewed by the USP Compounding Expert Committee and many of them are incorporated in the final published chapter. Read the Compounding Expert Committee’s responses to the public comments in the Commentary (posted Feb. 1, 2016).
- Download USP General Chapter <800>
Note: This chapter alone is not sufficient for a comprehensive approach to safe handling of hazardous drugs. Additional chapters are required for complete implementation; see USP Compounding Compendium or USP-NF
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