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 drugs to be hazardous that exhibit 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.
The General Chapter was first published on Feb. 1, 2016, in USP 39–NF 34, First Supplement, and will become official on July 1, 2018. The delayed official implementation date allows facilities more than two years to implement the new standard.
USP General Chapter <800> was published twice in the Pharmacopeial Forum or 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).
Developing USP General Chapter <800>
Public Health Need
The protection of 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 the 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 a well-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 <800>. Review their work plan and past meeting summaries.
<800> education courses (approved for 6.5 hours of CPE credit)