12.4 Hazardous Drugs: NIOSH 2024 List, USP 800 Controls, Assessment of Risk & Disposal
Key Takeaways
Oregon adopts USP 800 (v. 11/01/2023) by reference in OAR 855-183, and each site keeps a hazardous-drug list based on the NIOSH 2024 list, reviewed at least every 12 months.
A USP 800 assessment of risk may cover final dosage forms and antineoplastics that are only counted or packaged, but never active pharmaceutical ingredients, and is reviewed every 12 months.
Hazardous-drug compounding rooms are externally vented and kept at −0.01 to −0.03 inches of water column, and compounders wear two pairs of ASTM D6978 chemotherapy gloves.
CSTDs must be used when administering antineoplastic hazardous drugs if the dosage form allows, and staff are trained before handling hazardous drugs and at least every 12 months.
Oregon outlets must have written procedures for disposing of hazardous and pharmaceutical waste (OAR 855-041-1040).
Why this matters
The blueprint specifically lists "training, possession, handling, storage, and disposal of hazardous drugs." In Oregon, hazardous-drug handling is governed by USP General Chapter 800, adopted by reference in OAR 855-183 (v. 11/01/2023). It applies together with the NIOSH list of hazardous drugs, OSHA worker-safety rules and environmental waste rules. Hazardous-drug rules apply wherever these drugs are received, stored, compounded, dispensed or administered, not only in compounding.
Identifying hazardous drugs
- NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 (published December 2024). It replaced the earlier three-group format with two tables: Table 1 (drugs meeting the NIOSH definition with manufacturer special-handling information, or classified as carcinogenic, often antineoplastics) and Table 2 (other hazardous drugs). Each entity must keep its own list of hazardous drugs and review it at least every 12 months and whenever a new agent or dosage form is used (USP 800).
- Typical examples: oral and injectable antineoplastics (methotrexate, capecitabine, cyclophosphamide), hormonal agents (some estrogens and progestins, finasteride) and drugs with reproductive toxicity (such as valproate and mycophenolate).
Assessment of risk (AoR)
USP 800 lets an entity perform a documented assessment of risk for certain hazardous drugs, instead of applying every containment requirement:
- Allowed for final dosage forms of non-antineoplastic hazardous drugs and reproductive-only hazards, and for antineoplastics that only need counting or packaging.
- Not allowed for active pharmaceutical ingredients (APIs) or for antineoplastics that require manipulation.
- The AoR documents the drug, dosage form, exposure risk, packaging and manipulation, and the alternative containment and work practices. It is reviewed at least every 12 months.
Core USP 800 requirements
| Area | Requirement |
|---|---|
| Designated person | A qualified person responsible for the hazardous-drug program, training and compliance |
| Receipt and storage | Unpack antineoplastic HDs (and API) in a neutral or negative-pressure area, not positive pressure. Store antineoplastics requiring manipulation, and HD APIs, separately, in an externally vented, negative-pressure room with at least 12 air changes per hour |
| Compounding engineering controls | Containment primary engineering controls, such as a biological safety cabinet or compounding aseptic containment isolator, vented outside, inside a containment secondary engineering control (C-SEC) that is negative pressure, −0.01 to −0.03 inches of water column relative to adjacent areas. Sterile HD buffer rooms need at least 30 ACPH; nonsterile C-SECs at least 12 ACPH |
| Personal protective equipment | Two pairs of chemotherapy gloves tested to ASTM D6978 for compounding; impermeable gowns shown resistant to HD permeation; head, hair, shoe and sleeve covers; eye and face protection when splashes are possible. A surgical mask gives no respiratory protection. An N95 does not protect against vapors, and large spills need a full-facepiece chemical cartridge respirator or a PAPR |
| Closed-system drug-transfer devices (CSTDs) | Must be used for administering antineoplastic HDs when the dosage form allows. Should be used when compounding |
| Dispensing final dosage forms | Counting antineoplastic tablets on dedicated equipment and cleaning it after use. Avoid automated counters for antineoplastics unless the AoR allows |
| Cleaning | Deactivation, decontamination, cleaning and disinfection steps for HD work areas |
| Spill control | Spill kits where HDs are handled, trained staff and documented procedures |
| Training | Before handling HDs, and at least every 12 months, documented |
| Medical surveillance | Recommended for workers who handle HDs |
| Disposal | HD waste follows federal, state and local rules. Bulk and trace chemotherapy waste is segregated |
Oregon connections
- Policies: the outlet's written procedures must address the disposal of drugs and devices, including hazardous and pharmaceutical waste (OAR 855-041-1040). Employee training on those procedures is documented.
- Compounding outlets must comply with OAR 855-183, which adopts USP 800, and complete the Board's compounding self-inspection.
- Drug take-back: collection receptacles accept ultimate users' drugs, including hazardous drugs. Staff never handle the contents (section 11.4).
- Quarantine: damaged or spilled HD containers are quarantined and disposed of as hazardous waste. Federal RCRA hazardous-waste pharmaceutical rules (40 CFR 266 subpart P) apply to many healthcare facilities, along with Oregon DEQ requirements.
Tip
If an exam stem asks whether a retail pharmacy may count capecitabine tablets on the same tray used for all other drugs, the answer is no. Unless a documented assessment of risk permits otherwise, antineoplastic hazardous drugs need dedicated counting equipment that is cleaned after use, along with gloves and other USP 800 precautions.
Exam scenario
A community pharmacy dispenses oral methotrexate, finasteride and valproate, and compounds no sterile products. The designated person keeps the facility's HD list, reviewed every 12 months, and completes assessments of risk for the final dosage forms. Typical controls are counting methotrexate on a dedicated tray with chemotherapy gloves and avoiding crushing or splitting. Staff are trained before handling HDs and annually. The pharmacy keeps a spill kit and follows its written hazardous-waste disposal policy. If it began compounding hazardous preparations, it would also need USP 800 engineering controls, under OAR 855-183, and must notify the Board within 15 days of starting to compound.
For which item may an entity NOT use a USP 800 assessment of risk instead of full containment requirements?
Finasteride tablets dispensed in final dosage form
Methotrexate tablets that are only counted and packaged
Bulk active pharmaceutical ingredient of an antineoplastic used for compounding
Valproic acid capsules dispensed in final form
What pressure relationship does USP 800 require for the containment secondary engineering control (room) where hazardous drugs are compounded?
Positive pressure of at least 0.020 inches of water column
Neutral pressure relative to adjacent areas
No pressure requirement if a biological safety cabinet is used
Negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas, with external venting
How often must personnel who handle hazardous drugs be trained under USP 800?
Before they first handle hazardous drugs and at least every 12 months, with documentation
Only when hired
Every five years with PIC training
Only after a spill
Sections you finish are checked off in the contents.