USP General Chapter <800> establishes standards for handling hazardous drugs in healthcare settings. NIOSH List of Antineoplastic and Other Hazardous Drugs — Table 1 antineoplastic (cytotoxic and non-cytotoxic anticancer), Table 2 non-antineoplastic meeting one or more NIOSH HD criteria (carcinogenicity, teratogenicity, reproductive/developmental toxicity, organ toxicity at low doses, genotoxicity, structure/toxicity profile similar to existing HDs), Table 3 reproductive-effects-only. Assessment of Risk pathway — for Table 2/3 substances and antineoplastic dosage forms not requiring manipulation beyond counting/repackaging, entity may document AoR defining alternative containment strategies (drug type, dosage form, packaging, manipulation, exposure routes, mitigation); 12-month review minimum. Sterile HD compounding — Containment Primary Engineering Control (Class II Type B2 BSC or CACI) externally vented in ISO Class 7 Containment Secondary Engineering Control buffer room with negative pressure 0.01-0.03 inches water column, 30 air changes per hour, externally vented, with anteroom. Non-sterile HD compounding — Containment Ventilated Enclosure or Class I BSC in non-classified C-SEC with negative pressure and 12 ACH. Storage — dedicated negative-pressure area 12 ACH. PPE — chemo-rated ASTM D6978 gloves double-gloved when compounding, ASTM-rated single-use back-closure fluid-resistant gown, head/hair/shoe covers, eye/face protection, NIOSH-approved respirator for spills. Deactivation/decontamination/cleaning three-step process (sodium hypochlorite then thiosulfate then germicidal detergent typical). Environmental wipe sampling every 6 months with trending; commonly-referenced cyclophosphamide benchmark 1 ng/cm². Personnel competency training initial and 12-month reassessment; medical surveillance program recommended. Spill kits, eye-wash, post-exposure protocol documented. Intersects USP <795> and <797> 2023 revisions, OSHA HazCom (29 CFR 1910.1200), state Boards of Pharmacy and CMS Conditions of Participation from November 2023. Joint Commission and DNV accreditation surveys assess <800> compliance.

Regulatory anchors

USP General Chapter <800>
USP General Chapter <795>
USP General Chapter <797>
29 CFR 1910.1200
NIOSH List of Antineoplastic and Other Hazardous Drugs

Industries that live with this

Pharmaceutical Vet Pharma Radiopharma

How V5 handles it

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Audits that change the next batch.

Checklist apps stop at the PDF. V5 keeps going — a failed line opens a non-conformance, optionally a CAPA, optionally a lot hold, optionally a supplier scorecard hit, optionally a training reassignment. The loop closes itself.

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.