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New EPA Pharmaceutical Hazardous Waste Rules Coming Soon

Posted on 11/12/2018 by Roger Marks

US EPA is preparing to finalize regulations that could have a major impact on the way healthcare facilities and others manage pharmaceutical hazardous wastes. 
As proposed, EPA’s new pharmaceutical hazardous waste regulations will revise the rules for accumulating, counting, labeling, shipping, and disposing of these hazardous wastes. In other words, healthcare facilities should expect major changes to the way they manage pharmaceutical hazardous waste on site.

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Revisions in the proposed rule will: 
  • Prohibit drain disposal of pharmaceutical hazardous wastes.
  • Split pharmaceutical hazardous wastes into “creditable” and “non-creditable” categories, subject to different management and shipping requirements.
  • Establish hazardous waste management training requirements for personnel.
  • Create new rules and time limits for on-site accumulation/storage.
  • Exclude pharmaceutical hazardous wastes from counting toward generator status.
  • Create new labeling rules for pharmaceutical hazardous wastes.
  • Establish recordkeeping and release response requirements.
  • Establish a new facility category under RCRA: “Pharmaceutical Reverse Distributors.

Hazardous Waste Management Challenges for Healthcare Providers

 Healthcare facilities face three major challenges when it comes to hazardous waste compliance:
  1. Most healthcare professionals have their hands full with patient care, and most have little to no training or background in environmental compliance.
  2. Healthcare facilities may manage thousands of regulated pharmaceutical products that are each subject to specific management and disposal standards.
  3. Some pharmaceutical hazardous wastes are even regulated as “acute” hazardous wastes, meaning they are more dangerous and regulated more stringently.


Given those challenges, facilities need an effective hazardous waste management training plan in place to ensure compliance. Failure to comply with EPA’s hazardous waste regulations can result in rejected or returned pharmaceutical shipments, liability for environmental damage, and civil penalties under EPA’s RCRA program (now more than $72,000 per day, per violation).

Learn more about EPA’s proposed rules for pharmaceutical hazardous waste at the links below: 

New Management Standards for Hazardous Waste Pharmaceuticals (09/2015)
What’s in the Newly Proposed Subpart P for Hazardous Waste Pharmaceuticals (09/2015) 
Lion News will post an update when the Final Rule hits the Federal RegisterSUBSCRIBE NOW and ensure you get the latest hazardous waste management news delivered directly to your inbox, every Tuesday morning! 

Tags: hazardous, management, new, P, pharmaceutical, RCRA, rules, subpart, waste

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