- Safety and Health Topics
- Hazardous Drugs
This section highlights OSHA standards and guides to letters of interpretation (official letters of interpretation of the standards) and both State and professional standards related to hazardous drugs. Some agents have specific OSHA standards, but many of the requirements arise out of professional documents and good management practices.
The Oncology Nursing Society/American Society of Clinical Oncology guidance provides extensive guidance on program development and management, including an implementation guide.
USP 797, and now 800, provide the national professional standard for pharmacy processes to protect the safety and health of employees, not only patients. These standards include infrastructure maintenance standards, such as guide management of biosafety cabinets, that go far beyond the Centers for Disease Control and Prevention’s (CDC) biosafety guidance.
Other relevant standards come from the National Sanitation Foundation on biosafety cabinets.
General Industry (29 CFR 1910)
- 1910.1020, Access to employee exposure and medical records. OSHA requires the reporting of employee exposure to hazardous medications, and allows access to these records by employees.
- 1910.1200, Hazard communication. Includes the coverage of drugs and pharmaceuticals in the non-manufacturing sector. Requires any drugs posing a health hazard (with the exception of those in solid, final form for direct administration to the patient, i.e., tablets or pills) be included on lists of hazardous chemicals to which employees are exposed. In compliance with this standard all personnel involved in any aspect of the handling of covered hazardous medications must receive information and training to appraise them of the hazards in the work area. [related topic page]
- 1910.1450, Occupational exposure to hazardous chemicals in laboratories
Letters of Interpretation
- MSDS's must be provided to employees who package/process drugs for distribution into final form if they contain hazardous chemicals. (February 8, 2005).
- Hazard communication standard and pharmaceuticals. (January 3, 1994). Explains that the pharmaceutical manufacturer and the importer have the primary duty for the evaluation of chemical hazards and that the employer may rely upon the hazard determination performed by the pharmaceutical manufacturer or importer.
- MSDS Requirements for Drugs. (August 13, 1993). Provides a response to a letter specifically questioning the requirements for material safety data sheets (MSDS) for drugs.
Note: These are NOT OSHA regulations. However, they do provide guidance from their originating organizations related to worker protection.
- Hazardous Drugs Rule. Washington State Department of Labor & Industries. Adopted on January 3, 2012 and took effect in 3 stages January 1, 2015.