WHO publishes the official list of hazardous drugs in the health care setting?

Healthcare workers can be exposed to dangerous drugs during their daily practice. The National Institute for Occupational Safety and Health (NIOSH) considers “hazardous drugs” as those that had shown one or more of the following characteristic in studies with animals, humans or in vitro systems: carcinogenicity, teratogenicity or other toxicity for development, reproductive toxicity, organ toxicity at low doses, or genotoxicity. In the actual list (draft list 2020), drugs classified in group 1 are those with carcinogenic effects. Moreover, the global human and veterinary cancer is expected to grow, so antineoplastic drug consumption may consequently grow, leading to an increase of anticancer pharmaceuticals in the environment. Not all drugs pertaining to group 1 can be classified as “antineoplastic” or “cytostatic”. Since most of the research on environment presence and ecotoxicological effects of pharmaceuticals has been focused on this therapeutic class, other carcinogenic drugs belonging to different therapeutic groups may have been omitted in previous studies. In this study we aim to review the presence in the environment of the hazardous drugs (NIOSH group 1) and their possible environmental impact. Of the 90 drugs considered, there is evidence of presence in the environment for 19. Drugs with more studies reporting positive detections are: the antibiotic chloramphenicol (55), the alkylating agents cyclophosphamide (39) and ifosfamide (30), and the estrogen receptor modulator tamoxifen (18). Although the original purpose of the NIOSH list and related documents is to provide guidance to healthcare professionals in order to adequately protect them from the hazards posed by these drugs in healthcare settings, we believe they can be useful for environmentalists too. Absence of data regarding the potential of environmental risk of certain hazardous drugs might tell us which drugs ought to be prioritized in the future.

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. 

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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.

Important Updates

  • June 26, 2020 – Revision Bulletin published to clarify the term ‘antineoplastic’ for the purpose of Chapter <800>
  • December 1, 2019 – Official date for General Chapter <800>
  • May 31, 2019 – Revision Bulletin published to confirm the official date of USP General Chapter <800>
  • February 1, 2016 – Publication Date of General Chapter <800>

Note: General Chapter <800> is informational and not compendially applicable.
For more information on other compounding chapters click here.


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 Process

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. 

What organization maintains and publishes the list of hazardous drugs?

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services announces that the following draft documents are available for public comment: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs ...

Which organization publishes the list of antineoplastic and other hazardous drugs in healthcare settings?

The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and other HDs used in healthcare.

What document is the source for a list of hazardous drugs?

This hazardous drug list will be posted on the NIOSH Web site at www.cdc.gov/niosh. The OSHA hazard communication standard [29 CFR 1910.1200] requires employers to develop a hazard communication program appropriate for their unique workplace.

What is the NIOSH hazardous drug list?

The NIOSH List is an aid designed to enable employers to identify which drugs handled by employees are considered by NIOSH to be hazardous drugs. Because new drugs and new formulations are continuously brought to market between NIOSH's periodic updates hazardous drug evaluation should be a continual process.