Medical Waste Industry Insights

Unpacking the EPA’s Hazardous Pharmaceutical Waste Management Final Rule (Part 1)

By David Ryan

The EPA signed the final rule on hazardous pharmaceutical waste management on December 11, 2018. This updates the agency’s existing waste management by-laws to make them more in line with the needs of the healthcare organizations, while also ensuring environmental protection.


Let’s review everything that’s happening with this final rule:

What is the EPA hazardous waste management final rule?


The final rule is titled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine.” This rule carries forward from the proposed 2008 and 2015 EPA regulations that brought pharmaceuticals under the hazardous waste category, and defined their handling, shipment, and disposal by healthcare facilities and reverse distributors.


What does the final rule on hazardous pharmaceutical waste management entail?


EPA hazardous waste management final rule concentrates on a few key objectives and associated regulations:


  • Environmental protection: The rule is designed to reduce the pollution of drinking water sources, and prevent pharmaceutical waste run-off into water bodies. It bans the flushing of all hazardous waste and is expected to bring down the amount of waste going into the aquatic ecosystems by about 2,300 tons per year.

  • Regulate unused product: A key part of the ruling is the establishment of the proposed regulations around healthcare facilities’ management of unsold or unused pharmaceutical products. These products will be under the Resource Conservation and Recovery Act (RCRA) and could be sent to reverse distributors by healthcare organizations to receive manufacturers’ credit.

  • Recategorize nicotine waste: The final rule also brings about significant cost-savings to healthcare facilities with its regulations around nicotine waste. As per the rules, waste related to over-the-counter nicotine treatments are not categorized as hazardous waste, and so disposal and management will be less expensive.


What does EPA’s final rule on hazardous pharmaceutical waste management mean for waste generators?


As regards to the final rule’s impact on waste generators, there’s little that will change, except maybe make some regulations more flexible:


  • Small and large waste generators can manage their hazardous waste in accordance with the new regulation if they meet the criteria for a health-care facility or reverse distributor.

  • There can be certain exceptions granted to health-care facilities even when disposing of hazardous waste.

  • Regulations are more relaxed when it comes to disposing of containers with residual hazardous waste.

When does EPA hazardous waste management final rule take effect?


The rule was published in the Federal Register on December 14, 2018. It comes into effect at the federal level six months after its publication in the register. States have the ability to adapt the rules to their own requirements, except for the ban on flushing hazardous waste.


United Medical Waste Management helps health-care facilities manage their hazardous waste from cradle-to-grave, in complete compliance with the regulations. Contact us for a free waste audit and facility evaluation.

 

Learn more:

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Pharmacy Waste Principles & Best Practices: Download the Guide to Identify & Manage Waste Streams

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