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EPA's New Pharma Waste Regs Take Effect August 21

Posted on 6/5/2019 by Roger Marks

Overhauled requirements for managing hazardous waste pharmaceuticals (HWP) officially take effect on August 21, 2019. Health care facilities that manage pharmaceutical products and containers regulated under US EPA's Resource Conservation and Recovery Act (RCRA) regulations must update their waste handling and employee training procedures to maintain compliance. 

Proposed in 2015 and final as of February 22, 2019, the new standards will allow pharmaceutical distributors, healthcare facilities, and other sites that manage these wastes to exclude hazardous waste pharmaceuticals (HWP) from regulation under the more stringent RCRA hazardous waste management standards. In addition to the new HWP management standards, EPA is excluding some FDA-approved nicotine replacement therapies from regulations as  hazardous waste with this rulemaking. 

The relaxed standards are intended to streamline waste management for health care providers. In order to qualify for relief, hospitals and offices must take specific steps to train personnel, label containers, and comply with other new rules that affect the accumulation, storage, and disposal of these wastes. 

The new rule takes effect on August 21, 2019. 

Join an expert hazardous waste instructor live on June 18 for the final session of the Hazardous Waste Pharmaceuticals Rule Webinar. Find out what’s changing for healthcare facilities, distributors, and others who manage pharmaceuticals and contaminated empty containers.

New Rules for Managing HWP 

In addition to explicitly prohibiting discharges of hazardous waste pharmaceuticals into public sewer systems, the new EPA Final Rule lays out an extensive set of requirements that facilities must follow in order to qualify for the management relief.

New EPA requirements for hazardous waste pharmaceuticals include:

  • Training for certain employees who handle and accumulate these wastes
  • Hazardous waste determinations
  • New, unique accumulation rules and time limits
  • Specific labeling requirements for certain hazardous waste pharmaceutical containers  
  • Reporting, recordkeeping, and release response standards
  • Land disposal restrictions (LDR) for certain hazardous waste pharmaceuticals
  • Manifests for certain off-site shipments
The rule will likely affect generators of waste pharmaceuticals in the following NAICS industry sectors: 
Pharmacies, vet clinics, physicians’ offices, dentists’ offices, other health practitioners like chiropractors, outpatient care centers, other ambulatory health-care services, hospitals, nursing care facilities, continuing care retirement communities, some medical examiners and coroners’ offices, pharmaceutical manufacturers, and various other pharmaceutical reverse distributors.

Read the Final Rule in the Federal Register. 

Health-care workers often have their hands full with patient care. Deciding how to dispose of hazardous waste should be clear and easy for these employees so that they can focus on the important job of taking care of people. The sites affected by this Final Rule can manage thousands of regulated products, each subject to specific management requirements—some of which are even more strictly regulated as “acute” hazardous waste.

Live on June 18: Hazardous Waste Pharmaceuticals Webinar

EPA RCRA management of hazardous waste pharmaceuticalsOn June 18, Lion will present a live webinar to cover what’s changing for distributors and healthcare facilities, and others who manage pharmaceuticals and contaminated empty containers. Join an expert hazardous waste instructor for 90 minutes and get up to date on what you must do to achieve and maintain compliance with EPA’s new rules for hazardous waste pharmaceuticals. 

Tags: hazardous waste management,, hazardous waste pharmaceuticals, new, pharmaceuticals, RCRA, rules

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