The Globally Harmonized System (GHS) and OSHA
Manufacturers, importers, and distributors of hazardous drugs must comply with the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard (HCS), which is aligned with the international Globally Harmonized System (GHS). This standard mandates specific information on the labels of hazardous chemical containers that leave the workplace. These requirements ensure consistent, easily understandable hazard communication for users.
The six key elements required on a GHS-compliant label are:
- Product Identifier: The chemical or product name (e.g., product code, chemical name).
- Signal Word: Indicates the severity of the hazard using one of two words: 'Danger' for more severe hazards and 'Warning' for less severe ones.
- Hazard Pictograms: Standardized graphical symbols within a red diamond-shaped border. These visual icons communicate specific hazard types, such as health risks or flammability.
- Hazard Statements: Standardized phrases describing the nature and degree of the hazard (e.g., 'May cause respiratory irritation' or 'Highly flammable liquid and vapor').
- Precautionary Statements: Provides guidance on safe handling, storage, and disposal to minimize risk.
- Supplier Identification: Includes the name, address, and telephone number of the manufacturer or supplier.
USP <800>: Labeling in Healthcare Facilities
While GHS and OSHA standards cover manufacturer-shipped products, healthcare facilities must also follow the internal guidelines set by the United States Pharmacopeia (USP) in its General Chapter <800>. USP <800> outlines the specific requirements for handling, storing, and labeling hazardous drugs to protect healthcare workers, patients, and the environment.
One of the first steps for compliance is for a facility to develop and maintain an inventory of hazardous drugs, cross-referencing against the NIOSH List of Hazardous Drugs. All containers and storage areas for hazardous drugs must be clearly identified. Common practices include using dedicated ancillary labels with specific messages and bold colors. For example, a common label is a yellow-colored sticker with a 'CAUTION: Hazardous Drugs' warning.
Examples of specialized internal handling labels include:
- Chemotherapy Labels: Brightly colored, often yellow or orange stickers, specifically for cytotoxic drugs to remind staff of necessary handling precautions.
- Compounding Labels: Special labels for compounded hazardous drugs that include the beyond-use date, storage requirements, and batch information.
- Disposal Labels: Affixed to waste containers to ensure proper handling and disposal of hazardous drug waste.
- Patient Labels: For oral hazardous medications, some pharmacies add a special symbol or auxiliary warning to patient prescription labels to remind patients and caregivers of proper handling and disposal.
Key Differences in Labeling Standards: A Comparison
To understand the full scope of hazardous drug labeling, it's helpful to see the distinctions between manufacturer and internal facility requirements.
| Feature | OSHA HCS / GHS (Manufacturer/Supplier) | USP <800> (Healthcare Facility) |
|---|---|---|
| Regulatory Scope | Regulates the labeling of shipped hazardous chemical containers. | Sets standards for internal handling, storage, and preparation of hazardous drugs. |
| Primary Purpose | Standardized communication of inherent hazards for transport and initial use. | Safe handling and protection of personnel, patients, and the environment. |
| Label Content | Requires 6 specific GHS elements, including pictograms, signal words, and hazard statements. | Requires clear identification of HDs in storage and throughout the handling process. |
| Pictogram Style | Standardized red diamond frames with black symbols, mandatory for shipped containers. | Often uses bold text, contrasting colors (e.g., yellow, orange), and specific symbols for internal use. |
| Internal Labels | Employers must ensure labels are maintained, but are not responsible for creating manufacturer labels. | Facility is responsible for creating and applying internal labels for storage, compounding, and patient administration. |
| Workplace Signage | Allows for alternative written materials like signs for stationary containers. | Requires clear signage and access restriction for all HD handling areas. |
Beyond the label: Supporting Documentation
Labels are the first line of defense, but they are supported by critical documentation that provides more detailed information.
- Safety Data Sheets (SDS): Provided by manufacturers, these comprehensive documents detail a hazardous drug's potential hazards, safe handling procedures, and emergency response information.
- Manufacturer Package Inserts: Contains important safety information, including boxed warnings, warnings and precautions, and handling instructions.
- NIOSH List of Hazardous Drugs: The definitive resource for identifying drugs considered hazardous, which is updated periodically. The list is available on the CDC website and is a core component of a facility's HD inventory.
Conclusion: The Integrated Approach to Hazardous Drug Labeling
Effective labeling of hazardous drugs is a multi-faceted and regulated process that evolves from the point of manufacture to the moment of administration. Manufacturers follow internationally standardized GHS rules enforced by OSHA, while healthcare facilities must adhere to stringent internal guidelines laid out by USP <800>. By using a combination of GHS-compliant external labels, distinct internal warning stickers, and supporting documentation like SDS and the NIOSH list, facilities can ensure all personnel are properly alerted to potential risks. This integrated approach is fundamental to protecting healthcare workers and patients from the serious health effects associated with hazardous drugs and is a cornerstone of safe medication handling practices.
Visit the NIOSH List of Hazardous Drugs in Healthcare Settings
