Guides

Hazardous drugs (USP <800>)

Keep the USP <800> hazardous-drug handling register — containment, PPE, spill kits, Assessment of Risk — with annual assessments and surface-wipe sampling on cadence.

This module keeps the hazardous-drug handling register aligned to USP <800> and the NIOSH hazardous-drug framework — a row for each drug and handling activity, with the engineering containment, negative-pressure area, PPE, and Assessment of Risk recorded. NIOSH Group 1 (antineoplastic) compounding is the highest-containment case.

Register handling

  1. Go to Hazardous drugs and use the Register hazardous-drug handling form.
  2. Choose the Site and enter the drug name.
  3. Pick the NIOSH group and the handling activity, and name the designated area.
  4. Tick the controls that are in place — engineering containment, negative-pressure area, required PPE confirmed, Assessment of Risk on file, and a spill kit available in the area.
  5. Click Register handling.

Read the register

  • Each row shows the drug, its NIOSH group, the activity, and the designated area, with badges for containment, negative pressure, PPE, and AoR.
  • A row turns amber when something needs attention: required containment not in place, antineoplastic compounding without a negative-pressure area, PPE not confirmed, no spill kit available in a handling area that must be contained, an assessment missing or overdue, or (for Group 1 compounding) wipe sampling missing or overdue.
  • An Assessment of Risk on file is the alternative-containment basis for Group 2/3 handling — it cannot waive containment for Group 1 (antineoplastic) drugs.

Keep the cadence

  • Assess… opens the assessment editor: re-verify each control (containment, negative pressure, PPE, Assessment of Risk, spill kit) as found today, add notes, and save — the assessment date and the control state update together. Assessments run on an annual cycle.
  • Wipe sampled records a surface wipe sample taken today. For antineoplastic compounding, wipe sampling is expected roughly every 6 months.

Correct a gap

Use the CAPA button on a row to raise a corrective action for that handling entry — you can name an owner and due date right there. Once raised, the row links to that CAPA so you can track it to closure.

Export the register

Click Export register CSV to download the full register — controls, assessment and wipe dates, and each entry's open gaps — ready for a surveyor or pharmacy compliance review.

What happens automatically

  • When a program assessment goes overdue, the escalation sweep notifies the Safety Team with the drug, designated area, and due date.
  • Antineoplastic compounding running without full containment escalates immediately — it is an active exposure, not just a dashboard number. A lapsed wipe-sampling cadence escalates too.
  • The dashboard counts handling entries needing attention and antineoplastic compounding running without full containment.

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