What it is
The chapter applies to drugs on the NIOSH list of hazardous drugs. By default, every one of them must be handled with the full containment requirements. An assessment of risk is the document that lets you use alternative containment strategies and work practices for certain drugs and dosage forms instead.
Which drugs can be included
- Drugs on the NIOSH list that are not antineoplastic.
- Drugs listed only because of reproductive risk.
- Final dosage forms of antineoplastic drugs that only need counting or packaging.
Any antineoplastic drug that has to be manipulated, and any hazardous drug in the form of an active pharmaceutical ingredient, must follow the full containment requirements. An assessment of risk cannot change that.
What it must cover
- The type of hazardous drug.
- The dosage form.
- The risk of exposure.
- The packaging.
- The manipulation involved.
For each drug and dosage form, write down the alternative containment and work practices you will use to keep staff exposure as low as possible.
Review it every 12 months
The assessment must be reviewed at least every 12 months, and the review has to be documented. Update it sooner when you add a new drug or dosage form, or when NIOSH changes its list.
Mistakes inspectors find
- One blanket statement covering every drug, with no drug-by-drug detail.
- No difference drawn between dosage forms. Counting a coated tablet is not the same as crushing it.
- A drug list that has not kept up with what is on the shelf.
- Staff who do not know which precautions apply to which drug.
- No record that the yearly review happened.
A format that works
Use a table with one row for each drug and dosage form. The columns are: why it is on the list, how you receive it, what you do to it, the exposure risk, the precautions you will take, and the date of the last review. It is easy to maintain, easy to train from and easy to hand to an inspector.
Reviewed 2026-11-12 by a practicing pharmacist. This guide is general information, not legal advice. Check the current USP chapters, your state board of pharmacy rules and your software agreements before you act on it.