PharmE^® News Alert

NIOSH Publishes 2024 List of Hazardous Drugs in Healthcare Settings

News Alert: December 23, 2024

NIOSH published the long-awaited NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 in the Federal Register on Thursday, December 19th, 2024. The revised list was also published on the NIOSH website at https://www.cdc.gov/niosh/docs/2025-103/default.html. As anticipated over the past few years, NIOSH significantly revised the format and placement of drugs on the list, reducing the three tables to two. Usage of the published list should also include the two prior NIOSH documents, Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, https://www.cdc.gov/niosh/docs/2023-129/2023-129.pdf?id=10.26616/NIOSHPUB2023129 and Managing Hazardous Drug Exposures: Information for Healthcare Settings, https://www.cdc.gov/niosh/docs/2023-130/2023-130.pdf?id=10.26616/NIOSHPUB2023130, both of which were published on April 27, 2023.

While the criteria for determining a hazardous drugs remains the same (carcinogenicity, developmental toxicity (including teratogenicity), reproductive toxicity, genotoxicity, organ toxicity at low doses, or a structure toxicity profile that mimics existing drugs determined to be hazardous, the tables have been reduced from three to two and the criteria for each table has therefore been revised. It’s also important to note that, with a few exceptions added earlier to the NIOSH website, the current list reviews new drug approvals or new safety-related warnings from FDA during the period from January 2014 through December 2015.

NIOSH includes the following bolded warning: Caution: Drugs purchased and used by a facility may have entered the marketplace after the list below was assembled. This list is not all inclusive. Drugs reviewed for this update were new drug approvals or received safety-related new warnings from FDA during the period from January 2014 through December 2015. The biggest change to the list is the format, which moves from three tables to two. Table 1 includes drugs that have a manufacturer special handling information (MSHI) in the package insert and/or meet the NIOSH definition of hazardous, are listed either in the National Toxicology Program (NTP) as a known carcinogen or are classified by the International Agency for Research on Cancer (IARC) as a Group 1 known human carcinogen or a Group 2A probably carcinogenic to humans. Table 2 includes all other drugs that meet one or more of the NIOSH criteria for a hazardous drug but not the criteria noted for Table 1. Drugs that exhibit adverse developmental and/or reproductive effects are also listed in Table 2.

In addition, a footnote on page 5 of the document notes: “When NIOSH becomes aware of recently approved drugs that include MSHI, it adds them to the List at that time.” It will be important to check the NIOSH website on a regular basis for future hazardous drug additions over time.

In terms of the extent of the changes, 35 drugs were moved from Table 1 to Table 2, 48 drugs were moved from Table 3 to Table 2, and 15 drugs were moved from Table 2 to Table 1, resulting in a total re-arrangement of the hazardous drug list with new criteria for the tables. Seven drugs were removed from the lists altogether.

It will behoove healthcare organizations to closely study the new list and update their policies and procedures accordingly, along with any necessary training of relevant staff, in the pharmacy, in nursing and other related areas. In addition, NIOSH makes it clear that the healthcare organization is responsible for evaluating all drugs purchased and used by the facility, especially those not covered by the timeframe of the current list.

PharmEcology offers a comprehensive hazardous drug identification and management program which is updated weekly. Contact us at 877-247-7430 or info@pharmecology.com for more information.

Please click here to view a pdf version of this alert.

• Posted: December 23, 2024