NIOSH Updates Hazardous Drugs List for 2024: What You Need to Know

The NIOSH (US National Institute for Occupational Safety and Health) updates its list of hazardous drugs periodically to reflect new findings and ensure workplace safety standards.

In 2024, NIOSH revised its list of hazardous drugs to enhance workplace safety and protect healthcare professionals from potential health risks associated with handling these substances. The updated list includes new additions and modifications based on the latest research and evaluations.

Key Updates in NIOSH List of Hazardous Drugs in Healthcare Settings, 2024, include:

NIOSH has established formal procedures for adding, removing, or categorizing drugs on its List of Hazardous Drugs in Healthcare Settings, considering only those approved by the FDA’s Center for Drug Evaluation and Research (CDER). A drug is classified as hazardous if it is not regulated by the U.S. Nuclear Regulatory Commission and either has manufacturer’s special handling information or meets toxicity criteria such as carcinogenicity, reproductive toxicity, or genotoxicity.

However, drugs with molecular properties that limit health risks for healthcare workers may be excluded from the list. The criteria for each table in the List were adjusted in 2024 and now there are only 2 tables instead of 3.

NIOSH follows a sequential process to assess whether an FDA CDER-approved drug meets its definition of a hazardous drug. This includes reviewing FDA databases, analyzing molecular properties and manufacturer-provided data, synthesizing evidence from toxicity studies, and applying established hazard criteria. Decisions are subject to reevaluation, allowing for updates to the List as new information emerges.

The NIOSH List helps employers identify hazardous drugs handled by employees, but since new drugs and formulations are constantly introduced, hazardous drug evaluation should be an ongoing process. Employers should develop their own procedures to assess new drugs and periodically update their facility-specific hazardous drug lists based on available toxicological data.

Investigational drugs, which may lack complete toxicity information, should be treated as hazardous if their mechanism of action suggests potential risks. A site-specific risk assessment, considering factors like dose, potency, and exposure potential, is recommended to inform risk management procedures, with additional guidance available from NIOSH and other professional organizations.

As new evidence emerges about the potential hazards of certain drugs, updates to the hazardous drug list are essential for ensuring workplace safety.
This latest update includes 25 newly identified drugs, reflecting a range of administration routes, solvent compatibilities, and drug types.

• Among these, 9 are tablets /capsules / orally administered, while 1 is supplied in a prefilled pen.
• In terms of solvent compatibility, all liquid formulations are aqueous based/powders to be reconstituted in aqueous solvent/diluent.
• The newly added injectables include 9 antibody-drug conjugates (ADCs), four small molecules, 1 monoclonal antibody (mAb), 1 peptide (prefilled pen), and 1 hormone.
• Additionally, 2 of the newly added drugs are for veterinary use, available as powders instead of traditional tablets or capsules.

These updates underscore the importance of continuous assessment and risk management when handling hazardous drugs in healthcare and veterinary settings.

Some drugs previously classified as hazardous have undergone reevaluation, leading to updates in their classification and handling guidelines. In some cases, a substance was determined to be an infectious agent rather than a drug under FDA regulations. In others, NIOSH reviewed manufacturer-provided studies and found no significant evidence of carcinogenic, reproductive, or developmental risks for healthcare workers, resulting in its removal from the hazardous drug list. Additionally, certain drugs have been reclassified based on reproductive studies confirming a lack of reproductive toxicity. These updates ensure that classifications reflect the most current scientific data and workplace safety considerations.

NIOSH provides comprehensive guidelines for the safe handling of hazardous drugs, emphasizing the importance of proper precautions to minimize exposure risks. These guidelines include recommendations for using appropriate personal protective equipment (PPE) such as gloves, gowns, and respiratory protection, as well as implementing engineering controls like ventilated cabinets and negative pressure rooms, and the use of CSTDs as a supplemental protective measure. Additionally, NIOSH outlines safe handling procedures, including proper storage, transport, and disposal methods, to protect healthcare workers from potential drug-related hazards.

Exposure to hazardous drugs in healthcare environments can pose significant health risks, including reproductive toxicity, carcinogenicity, and damage to organ systems. Healthcare and veterinary professionals who handle these drugs may face long-term health effects if proper precautions are not taken. To minimize these risks, strict adherence to safety protocols—such as those outlined above in NIOSH Guidelines—is essential in preventing exposure and ensuring workplace safety.

Employers are required to implement robust safety programs that align with NIOSH recommendations, ensuring healthcare workers are protected from hazardous drug exposure. These programs must include comprehensive training, equipping staff with the knowledge to safely handle hazardous drugs based on their specific roles, whether in compounding, administration, or disposal. Training should be regularly updated to reflect evolving regulations such as USP <800>.

In addition to training, employers must establish clear identification and labeling of hazardous drugs to prevent accidental exposure. Providing Safety Data Sheets (SDSs) ensures staff have immediate access to critical information on hazardous drugs, protective measures, and emergency protocols.

Employers must also incorporate engineering controls to minimize exposure risks, including closed system drug-transfer devices (CSTDs), biological safety cabinets, and proper ventilation systems. Access to proper disposal equipment, such as sharps containers and spill kits, further ensures safe handling. By implementing training, continuous monitoring, and regular program updates based on NIOSH recommendations, employers can create a safer workplace and reduce the risks associated with hazardous drug exposure.

Simplivia’s Chemfort^® Closed System Drug-Transfer Device (CSTD) provides a brilliantly simple and highly effective solution for safely handling hazardous drugs safely. By preventing the escape of hazardous liquids, aerosols, and vapors, Chemfort^® significantly reduces the risk of cytotoxic drug exposure while meeting the rigorous safety standards of the unified NIOSH draft protocol (2016). Its leak-free disconnection, microbial ingress protection, and compatibility with all known hazardous drugs ensure both sterility and workplace safety. Chemfort^® is compatible with all known hazardous drugs, including the 25 drugs recently added to the NIOSH Hazardous Drug List in 2024.

Chemfort^® additionally optimizes healthcare efficiency and cost-effectiveness. Its streamlined design minimizes overstocking, reduces handling time, and allows multiple connection-disconnection cycles, lowering waste and overall expenses.
Staying informed about NIOSH’s hazardous drug classifications is essential for maintaining a safe healthcare environment. For the latest guidelines and more details, refer to the official NIOSH website. 

For a demo of Simplivia’s Chemfort^® Closed System Drug-Transfer Device (CSTD) contact us.