USP <800> hazardous drugs

USP <800> compliance software for hazardous drug handling

Hazardous-drug operations need evidence for the handling activities performed: containment-area conditions, C-PEC records, personnel preparation, and documented assessments where applicable. CompliRx keeps that evidence connected to the rooms, equipment, and people it describes.

Assessment of risk documents that go stale without a review trigger

Negative-pressure readings tracked separately from the HD room record

HD-specific training and competency evidence scattered across employee files

Deactivation and decontamination cleaning logged on generic checklists

USP <800> hazardous drugs: supported workflows

HD risk assessment tracking

Maintain the hazardous drug list review and assessment of risk with structured records, review dates, and retrievable history.

Pressure and room monitoring

Monitor negative-pressure relationships and room conditions for HD compounding areas, with excursion alerts and investigation history.

HD personnel and equipment

Track hazardous-drug training, competency evidence, C-PEC certification records, and equipment maintenance in context.

HD cleaning and follow-through

Schedule deactivation, decontamination, and cleaning work with attribution, and connect exceptions to investigations and CAPA.

What facilities gain

  • A current, reviewable assessment of risk
  • Pressure evidence tied to the rooms it protects
  • HD training records retrievable by employee
  • Containment exceptions with documented follow-through

Connect a hazardous-drug review to the work it changes

When a facility introduces a hazardous drug or changes how it is handled, the review needs to reach beyond updating a spreadsheet.

  1. Retain the drug assessment, supporting documents, responsible reviewer and next review date.
  2. Review affected containment areas, pressure records, equipment certifications and handling procedures.
  3. Assign the relevant training and cleaning work, and investigate exceptions with the original room or assessment evidence attached.

USP <800> covers hazardous-drug handling. NIOSH maintains a drug-identification resource and updates; facilities must evaluate their own inventory and handling activities. An assessment of risk is not a blanket exemption from containment requirements.

Primary references: USP <800> FAQs, January 2026: scope and assessment of risk · NIOSH: Hazardous Drugs List and subsequent updates

USP <800> hazardous drugs: common questions

Is USP <800> only relevant to sterile compounding?

No. Hazardous-drug handling can involve nonsterile preparations as well. Identify the drugs and handling activities at your facility, then evaluate the applicable containment and work practices using the chapter and current source information.

Can a pressure chart replace a hazardous-drug assessment?

No. A pressure chart records one environmental condition. The assessment, equipment evidence, personnel preparation and handling procedures address different parts of the operation. CompliRx keeps those records connected.

Related compliance workflows

Run CompliRx for $399/month.

The 90-day pilot includes guided onboarding and configuration around how your facility actually operates.