USP <800> Hazardous Drug Handling and Compliance Overview

RELATED LINKS 

For additional resources to support daily pharmacy operations and compliance click HERE. 

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.