Search

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.

Never miss an update! Subscribe to Lion News and get a free weekly digest of the latest news and insights for EHS professionals, hazmat shippers, and emergency responders. 
 
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.

Customer_At_Pharmacy_310751366.jpg

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

Find a Post

Compliance Archives

Lion - Quotes

The instructor was very engaging and helped less experienced people understand the concepts.

Steve Gall

Safety Leader

Well designed and thorough program. Excellent summary of requirements with references. Inclusion of regulations in hard copy form, as well as full electronic with state pertinent regulations included is a great bonus!

Oscar Fisher

EHS Manager

Given the choice, I would do all coursework this way. In-person courses go very fast without the opportunity to pause or repeat anything.

Ellen Pelton

Chemical Laboratory Manager

Attending Lion Technology classes should be mandatory for every facility that ships or stores hazmat.

Genell Drake

Outbound Lead

I chose Lion's online webinar because it is simple, effective, and easily accessible.

Jeremy Bost

Environmental Health & Safety Technician

The instructor had knowledge of regulations and understanding of real-world situations. The presentation style was engaging and fostered a positive atmosphere for information sharing.

Linda Arlen

Safety & Environmental Compliance Officer

The instructor took a rather drab set of topics and brought them to life with realistic real-life examples.

Tom Berndt

HSE Coordinator

The instructor created a great learning environment.

Avinash Thummadi

CAD & Environmental Manager

The course was very well structured and covered the material in a clear, concise manner.

Ian Martinez

Hazmat Shipping Professional

This is the best RCRA training I've experienced! I will be visiting Lion training again.

Cynthia L. Logsdon

Principal Environmental Engineer

Download Our Latest Whitepaper

Knowing why TSDFs reject loads of hazardous waste—and the exact steps to follow if it happens—can reduce your anxiety and uncertainty about rejection.

Latest Whitepaper

By submitting your phone number, you agree to receive recurring marketing and training text messages. Consent to receive text messages is not required for any purchases. Text STOP at any time to cancel. Message and data rates may apply. View our Terms & Conditions and Privacy Policy.