Written and maintained by CASRAI Editorial Board
Last updated
Short answer
The NIOSH list of hazardous drugs is the National Institute for Occupational Safety and Health’s reference of drugs it considers hazardous to the workers who handle them. The current edition is the 2024 list, DHHS (NIOSH) Publication No. 2025-103, released in December 2024. It replaces the 2016 edition, adds 25 drugs, removes 7, and sorts drugs into two tables. It is advisory, not a legal requirement, and it is not all-inclusive.
What the NIOSH list of hazardous drugs is
The full title is NIOSH List of Hazardous Drugs in Healthcare Settings, 2024. NIOSH describes it as an aid that lets employers identify which drugs their employees handle are considered by NIOSH to be hazardous. It began as a sample list in a 2004 alert and was updated in 2010, 2012, 2014, 2016 and 2024. Earlier editions were titled NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings; the 2024 title drops the word antineoplastic on purpose, because not every listed drug treats cancer. Valganciclovir, for example, is listed in Table 1.
The list creates no legal obligation for employers. In NIOSH’s words it is “advisory in nature and informational in content.” It also covers only drugs approved for humans by FDA’s Center for Drug Evaluation and Research (CDER). Products approved by the Center for Biologics Evaluation and Research, such as vaccines, blood products and gene therapies, are not evaluated, although some CDER drugs approved under a biologics license application are listed and flagged in a BLA column.
How NIOSH decides a drug is hazardous
NIOSH’s published procedures define a hazardous drug as one that is approved for humans by CDER, is not otherwise regulated by the Nuclear Regulatory Commission, and meets either of two tests:
- the package insert carries manufacturer’s special handling information (MSHI) meant to protect workers; or
- the drug shows one or more of carcinogenicity, developmental toxicity (including teratogenicity), reproductive toxicity, genotoxicity, organ toxicity at low doses, or a structure and toxicity profile that mimics an existing hazardous drug.
MSHI means wording such as “follow special handling and disposal procedures.” NIOSH does not count packaging or temperature-control language as MSHI. For low-dose organ toxicity, the list’s footnote refers to a human dose of about 10 mg/day, or about 1 mg/kg/day in animals, that causes serious organ, developmental or reproductive toxicity. That range has been used industrially to set occupational exposure limits below 10 µg/m³; see the guide to PELs, TLVs and RELs for how such limits differ. A molecular property that limits effects on workers can lead to a not-hazardous determination.
Table 1 versus Table 2 in the 2024 list
The 2024 list has two tables. The rule for placement is the most commonly misunderstood part, so it is worth stating plainly.
| Question | Table 1 | Table 2 |
|---|---|---|
| Package insert has MSHI? | May have it; MSHI alone is enough to qualify | No MSHI |
| Carcinogen ranking | Meets the NIOSH definition and is NTP “known to be a human carcinogen” or IARC Group 1 or 2A, or has MSHI | Not NTP “known” and not IARC 1 or 2A |
| Meets the NIOSH definition? | Yes (or has MSHI) | Yes |
| Reproductive or developmental hazard only | Not a separate category | Flagged in a dedicated column |
| Columns | Drug, AHFS classification, MSHI, BLA, IARC/NTP classification | Includes the “Only Developmental and/or Reproductive Hazard” column |
Drugs with IARC 2B or NTP “reasonably anticipated” classifications are in Table 1 only when they have MSHI. Table 1 is therefore not “the chemotherapy table”: it includes non-antineoplastic drugs such as valganciclovir, and Table 2 holds drugs that meet the NIOSH definition without MSHI or a top-tier carcinogen ranking.
What changed from the 2016 list
The 2024 NIOSH list of hazardous drugs is a restructure as well as an update, and many summaries still describe the older layout.
| Item | 2016 edition | 2024 edition |
|---|---|---|
| Drugs | Baseline | 25 added (12 with MSHI), 7 removed |
| Tables | Five tables | Two tables |
| Reproductive-only drugs | Separate Table 3 | Folded into Table 2 with a flag column |
| Removed drugs | Table 4 | Replaced by a “changes to placement” section |
| Exposure controls by formulation | Table 5 | Removed; NIOSH states risk management is outside the scope of the list |
| Supplemental information | Included, with pregnancy categories | Column removed |
| BLA column | Not present | New |
| “Antineoplastic” descriptor | Used for Table 1 | No longer used |
The review behind the update covered new drug approvals and new FDA safety warnings from January 2014 to December 2015, plus recently approved drugs that carry MSHI through May 2023. Controls for handling now sit in the companion NIOSH publication Managing Hazardous Drug Exposures (Pub. 2023-130), and the method for building the list is in Procedures for Developing the NIOSH List (Pub. 2023-129).
Notices since publication
NIOSH adds new MSHI drugs when it is notified and folds them into the publication later. On July 17, 2025 it added datopotamab deruxtecan (Datroway), treosulfan (Grafapex) and telisotuzumab vedotin (Emrelis) to Table 1, all because their package inserts include MSHI. Anyone maintaining a facility list should check NIOSH’s publication page for current notices rather than rely on a downloaded copy of the PDF.
Building a facility-specific hazardous drug list
NIOSH itself says drugs a facility uses may have reached the market after the list was assembled, that the list may not be all-inclusive, and that employers should consider creating a facility-specific list. A checklist that follows the source:
- Start from the NIOSH tables, and add any notices NIOSH has published since the PDF.
- For each new drug the facility stocks, read the package insert for MSHI. Under the NIOSH definition, MSHI alone qualifies a drug.
- Treat investigational drugs NIOSH has not reviewed as hazardous until adequate information excludes them, when the mechanism of action raises concern.
- Run a site-specific risk assessment covering dose, potency, and exposure potential during routine handling, compounding, spills, broken devices, needlesticks, inadvertent contact and surface contamination.
- Draw on other professional guidance NIOSH names, including ASHP, USP and ONS.
For how a facility’s hazardous drug list connects to compounding requirements, see the guide to USP 800 cleanroom requirements. Downstream handling topics are covered in chemotherapy waste disposal, pharmaceutical waste disposal and the oncology infusion center supply checklist.
Common misunderstandings
- “It is a regulation.” The list creates no legal obligation; it is advisory.
- “Every listed drug is a chemotherapy drug.” Not so. Table 1 includes non-antineoplastic drugs, and the 2024 edition removed the antineoplastic label.
- “Anything not listed is safe.” The list may not be all-inclusive, and unreviewed investigational drugs may warrant hazardous handling.
- “The 2016 groups still apply.” The 2024 edition has two tables, not the older five-table layout.
- “The list tells me how to handle each drug.” The 2024 edition dropped its exposure-control table; controls are covered in a separate NIOSH publication.
FAQ
What is the NIOSH list of hazardous drugs?
It is NIOSH’s advisory reference identifying drugs it considers hazardous to healthcare workers who handle them, currently published as DHHS (NIOSH) Pub. No. 2025-103.
What is in the NIOSH list 2024 edition?
Two tables of drugs with AHFS classification, MSHI status, a BLA flag and IARC/NTP classification, plus a section on changes to placement. It adds 25 drugs and removes 7 compared with 2016.
Is the NIOSH hazardous drug list mandatory?
No. NIOSH states it creates no legal obligation for employers.
How often is the list updated?
Editions appeared in 2004 (as a sample list), 2010, 2012, 2014, 2016 and 2024, with interim notices adding drugs between editions.
Sources
All sources checked 2026-10-29.
- NIOSH, NIOSH List of Hazardous Drugs in Healthcare Settings, 2024, DHHS (NIOSH) Publication No. 2025-103 (doi 10.26616/NIOSHPUB2025103): https://www.cdc.gov/niosh/docs/2025-103/pdfs/2025-103.pdf (checked 2026-10-29).
- NIOSH publication page, including notices since publication: https://cdc.gov/niosh/publications/hcp/numbered/2025-103.html (checked 2026-10-29).
- NIOSH release of December 19, 2024: https://cdc.gov/niosh/newsroom/updates/upd-12-20-25.html (checked 2026-10-29).
