New standards for hazardous drug handling will affect ophthalmology

New standards for handling hazardous drugs by health care personnel—including some ophthalmic drugs—can be enforced by regulators starting Nov. 1, 2023.  

The standards affect ophthalmologists using mitomycin (MMC) and 5-fluorouracil (5-FU), two drugs considered hazardous by the National Institute for Occupational Safety and Health (NIOSH). The Academy and the American Glaucoma Society (AGS) have developed detailed guidance for members. 

Our organizations also recently met with United States Pharmacopeia (USP), the nonprofit organization that sets these standards, to gain clarity for the education of our members. United States Pharmacopeia does not enforce these standards, but state and federal regulators, including State Boards of Pharmacy, can enforce compliance.  

The Academy and AGS have received multiple inquiries regarding the new standards and their impact.   

We support a surgeon’s ability to use MMC and 5-FU in hospital outpatient departments and ambulatory surgery centers. Both commercially available and sterile compounded agents must be used with closed-system transfer devices and appropriate personal protective equipment. We encourage ophthalmologists to work with hospital outpatient departments and ambulatory surgery centers to develop appropriate risk for using these products in these settings. 

These safety protocols should include information about the drug, and training of affected personnel with their acknowledgment of the specific risk of the agent. Documents addressing the following issues need to be available in the facility and reviewed annually: 

• Type of Hazardous Drug
• Dosage Form
• Risk of Exposure
• Packaging
• Manipulation
• Alternative Containment Strategies or Work Practices to Minimize Occupational Exposure