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

Lion was very responsive to my initial questions and the website was user friendly.

Michael Britt

Supply Chain Director

The workshop covered a lot of information without being too overwhelming. Lion is much better, more comprehensive than other training providers.

George Alva

Manufacturing Manager

One of the best trainings I have ever received!

Brandon Morfin

EH&S Manager

The instructor was great, explaining complex topics in terms that were easily understandable and answering questions clearly and thoroughly.

Brittany Holm

Lab Supervisor

Having the tutorial buttons for additional information was extremely beneficial.

Sharon Ziemek

EHS Manager

The instructor was probably the best I ever had! He made the class enjoyable, was humorous at times, and very knowledgeable.

Mary Sue Michon

Environmental Administrator

Lion's training was by far the best online RCRA training I've ever taken. It was challenging and the layout was great!

Paul Harbison

Hazardous Waste Professional

I have over 26 years of environmental compliance experience, and it has been some time since I have attended an environmental regulations workshop. I attended this course as preparation for EHS Audits for my six plants, and it was exactly what I was looking for.

Frank Sizemore

Director of Regulatory Affairs

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

Ian Martinez

Hazmat Shipping Professional

Best course instructor I've ever had. Funny, relatable, engaging; made it interesting and challenged us as the professionals we are.

Amanda Schwartz

Environmental Coordinator

Download Our Latest Whitepaper

What to do before, during, and after a RCRA hazardous waste inspection to defend your site from rising State and Federal penalties.

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.