Question 1

Why screen drugs that aren't on the NIOSH List?

Accepted Answer

Because not on the List often means not assessed yet, not “not hazardous”. NIOSH updates its List every few years; the current one was published in December 2024, and its review reached only drugs approved years before that. The cancer drugs approved in the years since, and many older drugs, have no NIOSH answer. USP <800> still asks each facility to keep its own list of the hazardous drugs it handles, review it at least every 12 months, and review each new agent or dosage form against it. Clariscope reads those drugs' package inserts for the same criteria NIOSH uses and shows you the label language, so that review starts from evidence in the label rather than from a blank page.

Question 2

Does Clariscope make my pharmacy USP <800> compliant?

Accepted Answer

No. Clariscope is an information tool: it screens every drug, gathers the NIOSH List status and the special-handling and toxicity language from the package insert, and shows you the cited text. Everything else stays with your team: your qualified staff review the label language and make every determination under your own policies. Clariscope informs that work. It doesn't advise on it, doesn't make determinations, and isn't a substitute for your facility's own USP <800> program. A “not found” result does not mean that a drug is non-hazardous or that no special handling requirements apply.

Question 3

Is it useful for drugs already on the NIOSH List?

Accepted Answer

Less so, and Clariscope says so. For a listed drug the NIOSH Table is the answer, and your Assessments of Risk are likely done; the screener shows the Table up front. The full label read is still one click away if you want it. Where Clariscope earns its keep is everything off the List: new cancer drugs, the unlisted items on your formulary, and the drugs your annual list review has to look at.

Question 4

What are the new cancer drugs?

Accepted Answer

Every new cancer drug the FDA has approved since 2021 (new molecules only: no biosimilars, generics or new forms), and every new use of an approved one since 2023, from FDA's oncology approval notices. Each package insert is screened against the same criteria and shown with its score, and you can browse them by year or show only the drugs that are not on the NIOSH List. The list is refreshed weekly. Cell and gene therapies are not included.

Question 5

What does a score like 4/6 mean?

Accepted Answer

How many of six label criteria the package insert contains: manufacturer special-handling information, carcinogenicity, genotoxicity, developmental toxicity, reproductive toxicity, and organ toxicity at low doses. A higher number means more of NIOSH's criteria appear in the label: a screening signal, not a determination of how hazardous a drug is. The Beyond the NIOSH List tab uses it as a threshold: special-handling language, or at least four of the six. Two limits to keep in mind: almost every cancer drug's label carries developmental and reproductive warnings, so those two alone say little; and organ toxicity is flagged from the label's wording, so whether it occurs at low doses is for a pharmacist to confirm. One special-handling statement can matter more than three other findings, so open the findings to read the sentences behind each one. A low score does not mean that a drug is non-hazardous or that no special handling requirements apply.

Question 6

Can I search by drug name instead of NDC?

Accepted Answer

Yes, and you don't have to choose. Names and NDCs go in the same box, mixed freely: one per line, comma-separated, or a CSV export with an NDC or Drug column. An NDC names one product, so it is screened straight away. A drug name usually matches many, so the screener shows every matching FDA product first, each with its manufacturer, dosage form and NDC, and you pick the ones you want, filtering by manufacturer or form and sorting the list to find them. Both routes give the same package-insert read.

Question 7

How is my data used?

Accepted Answer

Clariscope saves nothing to a server. You look drugs up and the results stay in your browser (only your display preferences are kept, on your device). The drug names and NDC codes you screen are sent to the FDA openFDA API and DailyMed (NLM/NIH) to retrieve the matching package inserts, and (only when you choose to) to the AI reader. There are no accounts, so there's nothing to sign in to.

Question 8

What does it screen against?

Accepted Answer

Two things: the NIOSH List of Hazardous Drugs, 2024 (all 236 drugs, Tables 1 & 2) for list status, and each drug's current FDA package insert, read for the manufacturer's special-handling information and the toxicity signals in the NIOSH definition. The insert is the part that matters for a drug off the List: it is published the day the drug is approved, years before NIOSH can assess it.

Question 9

How does it read the package insert?

Accepted Answer

It scans the insert against the seven NIOSH hazardous-drug criteria (2024): manufacturer special-handling information (cytotoxic, antineoplastic, “special handling”), carcinogenicity, genotoxicity/mutagenicity, developmental/teratogenicity, reproductive/fertility toxicity, organ toxicity (flagged to verify at low/therapeutic doses), and drug-class/mechanism hints (e.g. antibody-drug conjugate, alkylating agent) for comparison against known hazardous drugs. It shows the exact sentences it found, and sets aside statements that are negated (“was not mutagenic”, “studies have not been conducted”), reported only in animals, or that name a test or a disease rather than a finding about the drug, listing them separately so you can review them yourself. You can also open an AI reading of the insert for a plain-language, cited walkthrough. The score counts the first six; the drug-class hint is shown for comparison and not scored.

Question 10

What if a drug has no insert on file?

Accepted Answer

Some repackaged, compounded, or very new products don't have a current FDA insert on file. Those rows are marked “No label found”. Try the code with or without its final package segment (e.g. 0338-9777 vs 0338-9777-01), or try the generic name. A “not found” result does not mean that a drug is non-hazardous or that no special handling requirements apply.

Explore package inserts against the NIOSH hazardous-drug criteria.

New cancer drugs, not yet on the NIOSH List.

Authoritative sources

Label language, quoted

Your determination

See Clariscope in action

Track label changes on NIOSH-listed drugs.

Questions compliance leads ask first.