We've been waiting since 2016 for a new NIOSH hazardous drug list to be released. Although the 2020 DRAFT sparked hope, today we finally have the updated “NIOSH List of Hazardous Drugs in Healthcare Settings, 2024”! Here are some unique and important changes that need to be known when updating (or developing) the required facility-specific hazardous drug list.
The new 2024 Hazardous Drug (HD) list follows the same format as the 2020 DRAFT. Notably, the list has been condensed from three tables in the 2016 list to two tables in the 2024 list, with 25 drugs added, 12 of which have manufacturer special handling instructions (MSHI), and 7 drugs removed. The new list assigns all drugs to two simplified tables packed with useful information.
The 2016 list featured three tables:
Antineoplastic drugs
Non-Antineoplastic drugs meeting one or more NIOSH criteria for hazardous drugs
Reproductive risk drugs
The NIOSH 2024 list retains these designations throughout but eliminates the separate categorization of antineoplastic drugs to only Table 1. This change acknowledges that not all antineoplastic drugs share the same mechanism of action (MOA), which require full containment strategies of USP 800.
In anticipation of the NIOSH 2020 DRAFT, USP made a one-line revision to USP 800, adding that “the term antineoplastic only refers to antineoplastic drugs included in Table 1 of the most current NIOSH List.” Consequently, per USP 800, antineoplastic drugs listed in Table 2 may be released of full containment of USP 800 as long as there is an Assessment of Risk (AOR) and an alternative containment strategy identified.
The 2 tables in the new 2024 list are:
Table 1 (think carcinogenic and/or special handling): Drugs with Manufacturer's Special Handling Instructions (MSHI) and/or meet one or more of the NIOSH Criteria for hazardous drugs (see below) AND are carcinogenic.
The MSHI column in Table 1 will be particularly useful in ensuring that important handling instructions noted by the manufacturer are not overlooked during risk assessments of non-antineoplastic drugs NOT requiring manipulation. Remember, if a MSHI exists, handling must be performed according to the manufacturer's instructions.
Table 2 (think hazardous but noncarcinogenic): Drugs that meet one or more of the NIOSH criteria for a hazardous drug (see below) but do not have a MSHI and are not carcinogenic.
Notably, Table 2 includes some antineoplastic drugs. A convenient column in Table 2 also indicates drugs that are primarily associated with developmental and/or reproductive toxicity.
Both tables include an AHFS Classification column, which identifies the drug's category, such as antineoplastic, anticonvulsant, gonadotropin, or antiviral agent. By utilizing the AHFS column in conjunction with the developmental and/or reproductive risk column, employees can continue to be educated on potential hazards they may encounter when handling these drugs.
Important Note: Although it’s good to have an official updated NIOSH list that helps bridge USP 800 gaps, the NIOSH 2024 update only includes hazardous drugs approved through December 2015. Therefore, facilities must identify and assess hazards for all drugs introduced to the market after December 2015.
Additionally, remember that NIOSH does not evaluate non-FDA/CEDR-approved drugs (biologics, vaccines) or investigational drugs. The facility must also evaluate these products for hazards, regardless of their approval date.
Here is a brief review on how to create/update the facility-specific hazardous drug list.
In brief, any drug appearing on the current NIOSH Hazardous Drug (HD) list must be included on the facility-specific HD list. Additionally, facilities must assess:
Newer drugs introduced after the current NIOSH list
Non-FDA/CEDR-approved drugs (biologics, vaccines)
Investigational drugs
To assess these drugs, evaluate whether they meet one or more of the NIOSH criteria for hazardous drugs:
Carcinogenicity
Teratogenicity
Developmental toxicity
Reproductive toxicity
Organ toxicity at low doses
Genotoxicity
Similarity in structure or toxicity profile to an existing hazardous drug
Remember to follow any Manufacturer's Special Handling Instruction (MSHI) if it exists.
This link will take you to the new NIOSH List of Hazardous Drugs in Healthcare Settings, 2024: https://www.cdc.gov/niosh/docs/2025-103/pdfs/2025-103.pdf?id=10.26616/NIOSHPUB2025103\
Pharmacist (BCSCP) and the founder of Soigner Solutions (Soigner Universal, LLC). Collectively, Steve has over 20 years experience in sterile compounding of non-hazardous and hazardous preparations (including non-sterile to sterile using API). He is also experienced in non-sterile compounding and has fully developed and implemented all-inclusive compounding programs including USP <800> hazardous drug programs since the release of <800> in 2016. Steve received his Doctor of Pharmacy degree from McWhorter School of Pharmacy and holds two other degrees from Samford University and Université Sorbonne.
Thank you for visiting my site. For more information please visit www.SoignerSolutions.com or email me directly at smilstead@SoignerUniversal.com
Comentarii