Hazardous Drugs: The NIOSH List and USP 800, Explained
Updated
A hazardous drug is dangerous to the person handling it, not necessarily to the patient taking it. That single sentence resolves most of the confusion on this topic. A drug can be perfectly appropriate for the patient it was prescribed for and still be something you need gloves, a gown and a ventilated cabinet to count.
Two documents govern the subject and they do different jobs. NIOSH says which drugs are hazardous. USP General Chapter 800 says what you must do about them. Exam questions often hinge on knowing which document owns which half. This page is one stop on our PTCB study guide.
What the exam wants you to know
Three things. First, the split of responsibility: NIOSH identifies, USP 800 regulates handling. Second, that a drug qualifies as hazardous by meeting any one of six criteria, not all of them. Third, that every facility must maintain its own hazardous drug list rather than simply pointing at the NIOSH one, because the entity list can add drugs NIOSH has not yet assessed.
The six NIOSH criteria
A drug goes on the list if it meets one or more of these. Learning the criteria is more useful than memorising drug names, because the criteria let you reason about a drug you have not seen before.
| Criterion | What it means |
|---|---|
| Carcinogenicity | The drug causes cancer, or is reasonably expected to, in humans or animals. |
| Teratogenicity or developmental toxicity | The drug causes birth defects or harms a developing foetus. |
| Reproductive toxicity | The drug impairs fertility or reproductive capability. |
| Organ toxicity at low doses | Serious organ damage occurs at doses far below the therapeutic range. |
| Genotoxicity | The drug damages DNA, which underlies both cancer and heritable defects. |
| Structure and toxicity profile mimicry | A new drug resembles an existing hazardous drug closely enough in structure and toxicity that it is treated as hazardous by analogy. |
How the NIOSH list is organised
The 2024 edition of the NIOSH list uses two tables. If your study material describes three, it predates the restructure and is out of date on this point:
- Table 1: antineoplastic drugs. The cytotoxic and cancer chemotherapy agents. This is the group with the strictest handling rules and the one that cannot be exempted through an assessment of risk when manipulation is involved.
- Table 2: non-antineoplastic hazardous drugs. Everything else meeting one or more criteria. This table is where technicians get caught out, because it includes ordinary-looking drugs that are hazardous on reproductive or developmental grounds rather than because they are chemotherapy.
Older editions carried a third table for drugs with reproductive effects only. Those drugs did not disappear, they were folded into the two-table structure.
What USP 800 requires
USP General Chapter 800 covers the whole path a hazardous drug takes through a facility: receipt, storage, compounding, dispensing, administration and disposal. The requirements technicians are most often tested on:
- An entity-specific list. Every facility handling hazardous drugs maintains its own list, reviewed at least every 12 months.
- Separate storage. Hazardous drugs are stored apart from other stock. Antineoplastics requiring manipulation need an externally vented, negative pressure room with at least 12 air changes per hour.
- Engineering controls. Containment primary engineering controls inside containment secondary engineering controls, externally vented, with negative pressure relative to adjacent areas.
- Trained personnel. Training before handling begins, competency documented, reassessed at least every 12 months.
- Spill kits and procedures. Available wherever hazardous drugs are handled, with staff trained to use them.
- Assessment of risk. The documented route to alternative containment for certain dosage forms, reviewed at least every 12 months, and not available for antineoplastics requiring manipulation beyond counting or repackaging.
Personal protective equipment
PPE for hazardous drugs is specified rather than generic, and the specifications are testable:
| Item | Requirement |
|---|---|
| Gloves | Powder-free and tested to ASTM D6978, the chemotherapy glove standard. Double gloving for compounding, with the outer glove over the gown cuff. |
| Gowns | Disposable, back-closing, lint-free, coated to resist permeation. Never worn out of the handling area. |
| Eye and face protection | Required where splashing is a risk, which the standard respiratory mask does not cover. |
| Respiratory protection | A fit-tested N95 or better for spills and for unpacking damaged shipments. A surgical mask is not respiratory protection. |
The single most quoted detail here is the glove standard: ASTM D6978. Ordinary exam gloves are tested for leaks, not for chemotherapy permeation, and the two are not the same test.
Where this sits on the exam
Hazardous drug handling straddles two domains. The identification and criteria side is Medications, and the handling, PPE and containment side is Patient Safety and Quality Assurance at 23.75% of the exam. The regulatory framing, particularly who publishes what, connects to Federal Requirements at 18.75%.
Frequently asked questions
What is a hazardous drug?
A hazardous drug is one that poses a risk to the healthcare worker handling it, separate from any benefit to the patient taking it. NIOSH classes a drug as hazardous if it meets any one of six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or close structural and toxicity resemblance to an existing hazardous drug. The point technicians miss is that a hazardous drug can be entirely safe for the patient it was prescribed for and still be hazardous to the person counting it.
What is the NIOSH list of hazardous drugs?
It is the reference list published by the National Institute for Occupational Safety and Health that names the drugs meeting its hazard criteria in healthcare settings. The 2024 edition is organised into two tables: Table 1 covers antineoplastic drugs, and Table 2 covers non-antineoplastic drugs that meet one or more of the hazard criteria. Earlier editions used three tables, splitting out drugs with reproductive effects, so an older study guide may not match the current structure.
What is USP 800?
USP General Chapter 800 is the standard that says what a facility must actually do about hazardous drugs. Where the NIOSH list identifies them, USP 800 governs handling: receipt, storage, compounding, dispensing, administration and disposal, plus the engineering controls, personal protective equipment, training and documentation that go with each step. Every entity that handles hazardous drugs must maintain its own list, built from the NIOSH list plus anything else it decides to treat as hazardous.
What is an assessment of risk under USP 800?
It is the documented exception process. Full USP 800 containment is the default for everything on the entity's hazardous drug list, but for certain dosage forms, notably final dosage forms of conventionally manufactured products, the entity may perform an assessment of risk and adopt alternative containment strategies instead. Antineoplastic drugs requiring manipulation beyond counting or repackaging cannot be handled this way. The assessment must be reviewed at least every 12 months and documented.
Do hazardous drugs need separate storage?
Yes. They are stored separately from non-hazardous stock, in a manner that prevents contamination and exposure, and antineoplastic drugs requiring manipulation must be stored in an externally vented negative pressure room with at least 12 air changes per hour. The separation is not just tidiness: it limits how far surface contamination can spread if a container leaks.
Who can handle hazardous drugs?
Anyone who does must be trained before starting, with competency documented and reassessed at least every 12 months. USP 800 also requires that personnel of reproductive capability confirm in writing that they understand the risks. Staff who are pregnant, breastfeeding or actively trying to conceive are commonly reassigned by facility policy, though the chapter frames this as an entity decision rather than a blanket prohibition.
Keep studying
Test the safety half with the patient safety quiz and the high-alert medications practice set, which covers the neighbouring idea of drugs that are dangerous to patients when given wrongly. For the regulatory half, the controlled substance schedules reference covers the other major federal classification system you need to keep straight from this one.
Official sources checked
- NIOSH: Hazardous Drugs in Healthcare Settings
- USP General Chapter 800: Hazardous Drugs, Handling in Healthcare Settings
PTCB Quiz Prep is an independent study resource, not affiliated with the Pharmacy Technician Certification Board. This page is exam reference framing, not workplace safety guidance: follow your employer's policies and the current NIOSH and USP documents.