Just before the holiday season, EPA issued its final rule for waste pharmaceuticals management. Due to the complex nature of handling waste pharmaceuticals within healthcare facilities, it became clear to EPA that these waste streams could no longer be managed with existing RCRA waste regulations. EPA previously tried to promulgate rules regarding pharmaceutical waste streams in 2008 and then again in 2015, however the agency was never able to finalize the regulations. The goal of the final rule is to eliminate hazardous waste pharmaceuticals from water bodies and drinking water.
Hazardous Waste Pharmaceuticals: A Primer
What is a hazardous waste pharmaceutical, you ask? Well, this is where it gets a bit tricky. A number of pharmaceuticals are already listed on the P- and U-lists—warfarin, nicotine, lindane and cyclophosphamide to name a few; however, it doesn’t end there. Remember, RCRA also defines hazardous wastes using four characteristics: ignitability, corrosivity, toxicity, and reactivity. Many drug formulations meet the definition of ignitability or toxicity, so they must be managed as hazardous wastes when they are being disposed. Facilities should also consider managing waste pharmaceuticals as hazardous wastes if they fit into one or more of the following categories:
- The pharmaceutical contains a P- or U-listed ingredient
- The pharmaceutical is on the National Institute of Occupational Safety and Health (NIOSH) Hazardous Drug Alert Appendix A
- Chemotherapy agents not already listed as RCRA hazardous
- Bulk pharmaceutical powders
- Vitamin or mineral supplements that contain chromium, selenium or cadmium that have not been tested to determine if they fail the toxicity test
Under the new rule, hazardous waste pharmaceuticals requirements have been added for healthcare facilities, long-term care facilities, as well as reverse distributors. Healthcare facilities and reverse distributors will now have to manage their hazardous waste pharmaceuticals under the newly created part 266, subpart P instead of under part 262. One of the most important changes is that facilities can no longer flush pharmaceuticals, also known as sewering. According to EPA, this change will lead to safer and cleaner drinking and surface water by reducing the amount of hazardous waste pharmaceuticals entering waterways by 1,644 to 2,300 tons every year.
New Hazardous Waste Pharmaceuticals Rule: What You Need to Know
The new rule also:
- Divides pharmaceutical hazardous wastes into “creditable” and “non-creditable” categories, which require facilities to manage onsite storage and shipping differently
- Establishes hazardous waste management training requirements for staff
- Adds new requirements and time limits for on-site accumulation/storage
- Excludes pharmaceutical hazardous wastes from affecting generator status
- Creates new labeling requirements for pharmaceutical hazardous wastes
- Establishes recordkeeping and release response requirements
- Establishes a new RCRA facility category called “Pharmaceutical Reverse Distributors”
To help facilities understand the changes, EPA has a webinar that goes over the important changes and requirements.
The new rule will go into effect six months after it’s published in the Federal Register. For states with an authorized RCRA program, the rules must be adopted before they can go into effect.
To learn how you can standardize and streamline your waste management programs, processes, and procedures, and ensure compliance for hazardous, universal, special, and municipal solid waste regulations, check out Cority’s Waste Management Solution or request a demo with an EHS expert today.
About the Author
Ian Cohen is the Product Marketing Manager for Cority’s Safety, Environmental, and Sustainability solutions. In this role, Ian works with Cority’s Sales, Product, and Success teams to develop Cority’s marketing strategy, product roadmap, and help deliver products to the market that are designed to meet clients’ needs in an ever-changing regulatory environment. Previously, Ian served as the Environmental Product Manager at Cority. Prior to joining Cority, Ian was an environmental specialist at Florida Power & Light Company, where he served as the project and program lead for the company’s enterprise-wide environmental compliance management system. Ian was also a member of the company’s sustainability lead team and supported annual reporting and a myriad of sustainability projects. Ian holds a Master’s in Environmental Science and Bachelor’s in Biology, both from the University of Tennessee at Chattanooga. His research is published in the peer reviewed journals Annals of Botany and Zoologica Scripta.