USP <800> and OSHA Hazardous Drug Safety Overview

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Introduction 

Handling hazardous drugs in a pharmacy setting requires alignment with both USP <800> standards and Occupational Safety and Health Administration (OSHA) regulations. Together, these frameworks promote the safety of employees, patients, and the environment by establishing expectations for safe handling practices, hazard communication, and workplace protections. 

Applicability and Regulatory Oversight 

USP <800> applies broadly to all healthcare settings where hazardous drugs are handled, including non-compounding pharmacies. 

OSHA requirements focus on workplace and occupational safety, particularly chemical hazard communication and employee protection. 

• Enforcement of USP <800> is determined at the state level. 
• Workplace safety regulations may follow Federal OSHA standards or OSHA-approved state plans. 
• Pharmacies should review state-specific requirements to ensure full compliance with both USP and OSHA expectations. 

Core USP <800> Requirements 

USP <800> establishes foundational elements for hazardous drug safety: 

• Hazard communication processes 
• Occupational safety practices 
• Designated oversight for hazardous drug compliance 
• Maintenance of a hazardous drug inventory 
• Risk assessments and access to Safety Data Sheets (SDS) 
• Structured handling activities across all stages, including: 
  • Receipt and storage 
  • Dispensing and transport 
  • Use of personal protective equipment (PPE) 
  • Cleaning, decontamination, and disinfection 
  • Spill management and disposal 
  • Environmental monitoring and medical surveillance 

Implementation varies depending on pharmacy services, layout, and the types of hazardous drugs handled. 

OSHA Hazard Communication Requirements 

OSHA requires all pharmacies to maintain a Hazard Communication Standard in accordance with 29 CFR 1910.1200. 

This standard ensures that employees are informed of chemical hazards and understand how to protect themselves. 

Key Components Include: 

• Identification of hazardous chemicals in the workplace 
• Proper labeling of containers 
• Access to Safety Data Sheets (SDS) 
• Employee education and training on chemical hazards 

OSHA Exemptions and Considerations 

Certain products may be exempt from SDS requirements under OSHA regulations but not necessarily USP <800> requirements: 

• Drugs in solid, final form for direct patient administration (e.g., tablets, capsules) 
• Over-the-counter (OTC) drugs packaged for retail sale 
• Drugs intended for personal employee use (e.g., first aid supplies) 

Additionally: 

• Consumer products or hazardous substances used in the workplace as intended by the manufacturer may be exempt if employee exposure does not exceed typical consumer exposure levels. 

When determining inclusion in a hazard communication program, consider: 

• Duration of exposure 
• Frequency of exposure 
• Potential risk to employees 

Integrating USP <800> and OSHA Practices 

USP <800> and OSHA requirements are complementary: 

• USP <800> focuses specifically on hazardous drug handling practices. 
• OSHA focuses on broader workplace safety and hazard communication. 

Together, they support: 

• Safe handling and storage of hazardous drugs 
• Clear communication of risks 
• Protection of pharmacy personnel from exposure 

Hazardous Drug Handling Activities 

Across both frameworks, pharmacies should address: 

• Designated hazardous drug areas 
• Receipt, storage, and transport protocols 
• PPE selection and use based on activity 
• Cleaning and decontamination procedures 
• Spill response and disposal 
• Environmental monitoring 
• Ongoing staff safety measures 

Documentation and Organization 

Maintaining organized and accessible documentation supports both compliance and operational efficiency. 

• Maintain a centralized collection of hazardous drug safety materials (e.g., compliance binder or digital equivalent) 
• Include inventories, SDS, training records, and safety guidelines 
• Ensure documents are current and readily accessible to staff 

Staff Education and Implementation 

Effective hazardous drug safety programs rely on staff awareness and engagement: 

• Provide training on hazard communication and safe handling practices 
• Ensure staff understand labeling, SDS usage, and PPE requirements 
• Reinforce safe work practices through ongoing education and updates 

Regular review of materials and practices helps maintain alignment with evolving regulations and workplace needs. 

Additional Resources 

For more detailed information, consult: 

• USP Hazardous Drugs Handling in Healthcare (USP <800>) 
• OSHA Hazard Communication Standard (29 CFR 1910.1200) 
• OSHA guidance on hazardous drugs and hazard communication 
• NIOSH hazardous drug resources and publications 

Key Takeaways 

• USP <800> and OSHA regulations work together to promote hazardous drug safety. 
• Compliance involves both safe handling practices and effective hazard communication. 
• Requirements may vary by state, making it important to verify local regulations. 
• Ongoing training, documentation, and review are essential for maintaining a safe 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.