---
title: USP <800> Hazardous Drug Handling and Compliance Overview
description: A comprehensive guide to USP <800> standards for hazardous drug handling, including staff training, risk assessment, storage, handling practices, and safety controls in pharmacy settings.
---

[Skip to content](https://kb.montanafamilypharmacies.com/reg-and-comp/usp-800-hazardous-drug-handling-and-compliance-overview#main-content)

English

Show submenu for translations

Montana Family Pharmacies

Open main navigation

Close main navigation

- English
  
  Show submenu for translations
- Contact us

 Contact us

 How can we help you?

- There are no suggestions because the search field is empty.

1. [Regulatory and Compliance](https://kb.montanafamilypharmacies.com/reg-and-comp?hsLang=en)
2. [Hazardous Drug Program](https://kb.montanafamilypharmacies.com/reg-and-comp/hazardous-drug-program?hsLang=en)
3. [Hazardous Drugs and USP-800](https://kb.montanafamilypharmacies.com/reg-and-comp/hazardous-drug-program?hsLang=en#hazardous-drugs-and-usp-800)

May 13, 2026

# USP \<800\> Hazardous Drug Handling and Compliance Overview

## A comprehensive guide to USP \<800\> standards for hazardous drug handling, including staff training, risk assessment, storage, handling practices, and safety controls in pharmacy settings.

**RELATED LINKS** 

For additional resources to support daily pharmacy operations and compliance click [HERE](https://members.montanafamilypharmacies.com/general-pharmacy-policy-procedure/). 

**Full Article:** 

**Introduction** 

USP Chapter \<800\> establishes standards for handling hazardous drugs in healthcare settings to protect patients, personnel, and the environment. These standards apply to all aspects of hazardous drug handling, including receipt, storage, preparation, dispensing, transport, administration, and disposal. This guide outlines the core elements of a compliant hazardous drug safety program. 

   
 

**Scope and Applicability** 

Hazardous drug handling practices apply to all pharmacy personnel involved in any stage of handling hazardous drugs, including: 

- Pharmacists 
- Pharmacy interns 
- Technicians and support staff 

   
 

**Key Definitions** 

**Hazardous Drug** 

A drug identified as hazardous based on characteristics such as: 

- Carcinogenicity 
- Teratogenicity or developmental toxicity 
- Reproductive toxicity 
- Genotoxicity 
- Organ toxicity at low doses 
- Structural similarity to known hazardous drugs 

**Active Pharmaceutical Ingredient (API)** 

A substance intended for use in drug preparation that provides pharmacological activity or therapeutic effect. 

   
 

**Oversight and Responsibility** 

A designated individual is typically responsible for overseeing hazardous drug compliance efforts. 

**Key Responsibilities Include:** 

- Supporting implementation of USP \<800\> standards 
- Ensuring staff competency and training 
- Monitoring environmental controls and safety practices 
- Promoting awareness of risks and safe handling practices 
- Supporting reporting and follow-up of safety concerns 

   
 

**Employee Training and Competency** 

Personnel handling hazardous drugs should receive training specific to their job responsibilities. 

**Training Expectations:** 

- Completed before independently handling hazardous drugs 
- Includes competency assessment and periodic reassessment (at least annually) 
- Updated when new drugs, equipment, or processes are introduced 

**Training Topics Typically Include:** 

- Hazardous drug inventory and associated risks 
- Safe handling practices 
- Use of personal protective equipment (PPE) 
- Use of engineering controls and equipment 
- Spill response and exposure management 
- Disposal procedures 
- Hazard communication principles 

   
 

**Hazardous Drug Inventory** 

Maintaining an accurate inventory of hazardous drugs is essential. 

- Use resources such as the NIOSH list of hazardous drugs 
- Review and update the inventory regularly (at least annually) 
- Evaluate new drugs to determine if they meet hazardous criteria 
- Include drugs with insufficient data until classification is clarified 

 

**USP \<800\> Containment Requirements ** 

Following USP \<800\> containment requirements is essential for program integrity.  

- Drugs on the NIOSH list that must follow all the requirements set forth in USP \<800\> include:   
    - Handling any hazardous drug API on the NIOSH list  
    - Handling any antineoplastic drug requiring manipulations, such as:   
          - Drawing methotrexate from a vial 
          - Crushing tablets or opening capsules to make a suspension  
          - Cutting tablets 
    - Handling dosage forms that do not fit into the pharmacy's assessment of risk 
- Drugs on the NIOSH list that do not have to follow all the containment requirements in USP \<800\> **IF** an assessment of risk is completed include:   
    - Handling final dosage forms of compounded hazardous drug preparations  
    - Conventionally manufactured hazardous drugs including antineoplastic dosage forms that do not require an further manipulation other than counting or repacking  
    - Handling non-antineoplastics or reproductive harm-only hazardous drugs. 

   
 

**Assessment of Risk** 

An Assessment of Risk helps determine appropriate handling precautions for each hazardous drug. 

**Key Elements Include:** 

- Drug name and classification (e.g., antineoplastic, non-antineoplastic) 
- Dosage form 
- Exposure risk 
- Packaging and handling requirements 
- Required containment strategies and work practices 

If no assessment is available, full containment precautions should be used. 

   
 

**Exposure Risks and Routes** 

Potential exposure to hazardous drugs may occur through: 

- Skin or mucosal contact 
- Inhalation 
- Injection 
- Ingestion 

**Common Activities with Exposure Risk:** 

- Receiving and unpacking shipments 
- Dispensing and repackaging 
- Compounding or manipulation 
- Administration 
- Cleaning and maintenance 
- Waste handling and disposal 
- Spill response 

 

**Personal Protective Equipment (PPE)** 

PPE requirements vary based on the drug and task. 

- Staff should consult risk assessments and Safety Data Sheets (SDS) 
- Appropriate PPE must be provided and used when handling hazardous drugs 
- PPE helps minimize exposure during all handling activities 

   
 

**Facilities and Engineering Controls** 

Safe handling environments should include: 

- Restricted access to hazardous drug areas 
- Separation from breakrooms and public areas 
- Clearly designated areas for:  
    - Receiving and unpacking 
    - Storage 
    - Processing and dispensing 
- Clearly labeled spaces and access to SDS, spill kits, and safety information 

   
 

**Receipt and Unpacking** 

- Hazardous drugs should be unpacked in designated areas 
- Use appropriate PPE during handling 
- Inspect shipments for damage or leakage 
- Clean external containers to remove residue 
- Transport drugs promptly to designated storage 

**Damaged Shipments:** 

- Treat as potential spills 
- Isolate and secure the package 
- Follow appropriate handling, return, or disposal steps 
- Clean and decontaminate affected areas 

   
 

**Storage of Hazardous Drugs** 

- Store hazardous drugs according to USP and manufacturer requirements 
- Prevent breakage and contamination 
- Avoid storage on floors 
- Segregate hazardous drugs when required or as a best practice 

 

**Handling and Dispensing** 

**Final Dosage Forms:** 

- Includes tablets, capsules, creams, or other forms requiring no further manipulation 
- Use appropriate PPE when handling 
- Perform tasks such as counting or repackaging carefully to avoid contamination 

**Manipulated Dosage Forms:** 

- Activities like cutting tablets or preparing suspensions may require additional controls 
- Dedicated equipment should be used and cleaned after each use 

   
 

**Labeling, Packaging, Transport, and Disposal** 

**Labeling:** 

- Clearly identify hazardous drugs requiring special handling 

**Packaging:** 

- Protect drug integrity and prevent leakage or contamination 

**Transport:** 

- Use secure containers to minimize breakage 
- Avoid pneumatic tube systems for certain hazardous drugs 

**Disposal:** 

- Follow all applicable regulations for hazardous waste 
- Include disposal of trace-contaminated materials and PPE 

   
 

**Administration** 

- Use appropriate safety devices and techniques 
- Wear PPE during administration 
- Dispose of all used materials as hazardous waste 

   
 

**Cleaning and Decontamination** 

Effective cleaning involves multiple steps: 

- **Deactivation:** Neutralize hazardous drug residue 
- **Decontamination:** Remove residue from surfaces 
- **Cleaning:** Remove organic/inorganic materials 
- **Disinfection:** Eliminate microorganisms (as applicable) 

Regular cleaning should occur after use and at the end of each day. 

   
 

**Spill Control and Response** 

- Spill kits should be readily available 
- Only trained personnel should respond to spills 
- Use appropriate PPE during cleanup 
- Isolate the area and contain the spill 
- Dispose of materials as hazardous waste 
- Document all incidents and evaluate for improvement opportunities 

   
 

**Hazardous Waste Disposal** 

- Dispose of hazardous drugs and contaminated materials according to federal, state, and local regulations 
- Ensure proper segregation, handling, and documentation 

   
 

**Environmental Monitoring (Optional)** 

- Surface wipe sampling may be used to assess contamination 
- Results can guide improvements in cleaning practices and controls 

   
 

**Medical Surveillance (Optional)** 

- May be used to monitor employee health related to hazardous drug exposure 
- Includes baseline and periodic health assessments 
- Helps evaluate effectiveness of safety controls 

   
 

**Quality Assurance and Review** 

Regular evaluation of hazardous drug handling practices supports ongoing safety and compliance. 

- Assess processes and controls periodically 
- Identify opportunities for improvement 
- Reinforce training and safe practices 

   
 

**Key Takeaways** 

- USP \<800\> provides a comprehensive framework for hazardous drug safety. 
- Effective programs include training, risk assessment, proper PPE use, and environmental controls. 
- Safe handling practices must be applied across all stages of the medication-use process. 
- Ongoing monitoring and review help maintain a safe and compliant pharmacy environment. 

 

Disclaimer: These tools and templates are intended for general informational purposes and are provided by Montana Family Pharmacies as a service to pharmacies. While we try to keep the information timely and accurate, we make no guarantees. These tools and templates are not a substitute for legal, regulatory, or professional advice. 

Policies and procedure, templates, checklists, and other tools should be customized to fit the specific needs and regulatory requirements of your pharmacy. 

Montana Family Pharmacies disclaims any liability for any damages, losses, or other consequences arising from the use or reliance on the tools or policy templates. 

- [DEA Compliance Program](https://kb.montanafamilypharmacies.com/reg-and-comp/dea-compliance-program?hsLang=en#main-content)

    - [DEA Readiness](https://kb.montanafamilypharmacies.com/reg-and-comp/dea-compliance-program?hsLang=en#dea-readiness)
    - [Licensing and Registration](https://kb.montanafamilypharmacies.com/reg-and-comp/dea-compliance-program?hsLang=en#licensing-and-registration)
    - [Safety and Security](https://kb.montanafamilypharmacies.com/reg-and-comp/dea-compliance-program?hsLang=en#safety-and-security)
    - [Ordering and Inventory](https://kb.montanafamilypharmacies.com/reg-and-comp/dea-compliance-program?hsLang=en#ordering-and-inventory)
    - [Prescriptions](https://kb.montanafamilypharmacies.com/reg-and-comp/dea-compliance-program?hsLang=en#prescriptions)
    - [Distributions and Losses](https://kb.montanafamilypharmacies.com/reg-and-comp/dea-compliance-program?hsLang=en#distributions-and-losses)
    - [Optional Programs](https://kb.montanafamilypharmacies.com/reg-and-comp/dea-compliance-program?hsLang=en#optional-programs)
- [Hazardous Drug Program](https://kb.montanafamilypharmacies.com/reg-and-comp/hazardous-drug-program?hsLang=en#main-content)

    - [Hazardous Drugs and USP-800](https://kb.montanafamilypharmacies.com/reg-and-comp/hazardous-drug-program?hsLang=en#hazardous-drugs-and-usp-800)
- [Wholesaler CSMP Guide](https://kb.montanafamilypharmacies.com/reg-and-comp/wholesaler-csmp-guide?hsLang=en#main-content)

    - [Navigating CSMP Audits](https://kb.montanafamilypharmacies.com/reg-and-comp/wholesaler-csmp-guide?hsLang=en#navigating-csmp-audits)
    - [Wholesaler Controlled Substances](https://kb.montanafamilypharmacies.com/reg-and-comp/wholesaler-csmp-guide?hsLang=en#wholesaler-controlled-substances)
    - [Wholesaler Injunctive Relief](https://kb.montanafamilypharmacies.com/reg-and-comp/wholesaler-csmp-guide?hsLang=en#wholesaler-injunctive-relief)
- [Operations and Compliance Checklists](https://kb.montanafamilypharmacies.com/reg-and-comp/operations-and-compliance-checklists?hsLang=en#main-content)

    - [Ops & Compliance](https://kb.montanafamilypharmacies.com/reg-and-comp/operations-and-compliance-checklists?hsLang=en#ops-compliance)
- [Pharmacy Daily Ops Program](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#main-content)

    - [Licensing, Legal, and Administrative](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#licensing-legal-and-administrative)
    - [Staffing, Supervision, and Access Control](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#staffing-supervision-and-access-control)
    - [Facility, Equipment and Environmental Controls](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#facility-equipment-and-environmental-controls)
    - [Inventory Management and Drug Handling](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#inventory-management-and-drug-handling)
    - [Procurement and Vendor Management](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#procurement-and-vendor-management)
    - [Pharmacy Systems and Patient Records](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#pharmacy-systems-and-patient-records)
    - [Prescription Intake and Processing](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#prescription-intake-and-processing)
    - [Dispensing, Labeling, and Clinical Review](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#dispensing-labeling-and-clinical-review)
    - [Patient Interaction and Services](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#patient-interaction-and-services)
    - [Workflow Exceptions and Prescription Adjustments](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#workflow-exceptions-and-prescription-adjustments)
    - [Special Sales and Packaging](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#special-sales-and-packaging)
    - [Daily Operations and Continuous Compliance](https://kb.montanafamilypharmacies.com/reg-and-comp/pharmacy-daily-ops-program?hsLang=en#daily-operations-and-continuous-compliance)

# Montana Family Pharmacies

<https://www.facebook.com/> <https://www.twitter.com/> <https://www.instagram.com/> <https://podcasts.apple.com/> [mailto:email@email.com](mailto:email@email.com)

Copyright © 2026, Montana Family Pharmacies