New Year. New EPA Rule.
It’s official. The Environmental Protection Agency’s (EPA) Final Rule regarding the management of hazardous pharmaceutical waste has been signed and is imminently ready to publish in the Federal Register. Under consideration for the past three years, the rule provides additional clarity that makes it easier for health care facilities to follow, fostering effective and appropriate hazardous pharmaceutical waste management.
What Prompted the EPA to Make Changes?
The EPA has had rules governing hazardous waste since 1976, in part by authorizing states to implement the Resource Conservation and Recovery Act (RCRA). Over the course of 40+ years, health care facilities struggled to comply with the regulations the EPA issued. The EPA released a proposal in 2015 on hazardous pharmaceutical waste disposal management with a focus on health care providers because of the challenge of following the current regulations. The final regulations make it easier and safer for health care organizations to comply and are designed to be more effective at keeping dangerous drugs out of waterways and other environmental areas.
When Does the EPA Hazardous Pharmaceutical Waste Rule Go into Effect?
Although the rule is final, the current RCRA regulations will continue to be enforced until the rule is effective, which will occur six months after publication in the Federal Register. States will be required to adopt the rule, but they will have the ability to make changes—thus the effective dates may vary by state.
The proposed ban on flushing pharmaceuticals is an exception. It will become effective in all states on the federal regulation’s effective date.
What Types of Health Care Organizations Are Impacted?
The regulations cover most health care entities that manage pharmaceutical products and waste, including hospitals, pharmacies, clinics, dental practices, skilled nursing facilities and long-term care organizations, as well as reverse distributors. The final rule does not cover pharmaceutical manufacturers (unless they act as reverse distributors) or production facilities.
What Are Some Important Takeaways?
Although the rule goes into detail on a variety of topics, the following are four key points to note:
- Within the requirements, the EPA has created two distinct hazardous pharmaceutical waste categories—those items that can be returned to a reverse distributor for credit and those that cannot. Each category has its own set of regulations of which organizations should be aware.
- There is a description of container requirements for hazardous pharmaceutical waste storage. Labeling and accumulation time are also addressed.
- Container storage is another topic covered in the rule, with the requirements underscoring the need to keep the public away from hazardous pharmaceutical storage areas.
- As with any revised regulation, there are training requirements to make sure that staff are knowledgeable about the changes and what impacts those may have on their day-to-day tasks.
These are just some of the areas the new regulations address. Stay tuned for upcoming articles on this topic in which we delve deeper into the details. In the meantime, learn more about the new rule and its ramifications on Stericycle’s Important Regulatory Summary.
