CUPA-2019 Session Details

EPA'S FINAL NEW PHARMACEUTICALS RULE
Thu, Feb 28    10am - 11:45am    57 of 180 seats available
TH-H2   Industry
Location   GRAND BALLROOM F
Credits      REHS: 2
   Objective
After attending this class, attendees will have a better understanding of the requirements of EPA's Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and its implications for DTSC, the CUPAs, and the regulated community.
   Description
For the past twenty years, EPA, state environmental protection agencies, and the regulated healthcare community have been aware of the difficulties of applying the Resource Conservation and Recovery Act hazardous waste regulations to pharmaceutical waste management in pharmacies and healthcare facilities. In 2008, EPA proposed that pharmaceutical waste be managed as universal waste, but withdrew this concept based on industry responses that indicated many issues would not be addressed. On September 25, 2015 EPA published its Proposed Rule: Management Standards for Hazardous Waste Pharmaceuticals. In the proposed rule, EPA created a new Subpart P Hazardous Waste Pharmaceuticals under Part 266, which carves out specific requirements for healthcare facilities, including pharmacies, and reverse distributors. The final rule is expected to be published in October, 2018 and will dramatically change many of the requirements for the management of hazardous waste pharmaceuticals. It is considered to be stricter than current regulations and must therefore be adopted by states authorized under the RCRA program. This session will compare and contrast the new hazardous waste pharmaceutical regulations with both the current EPA and California DTSC regulations as they apply to pharmaceutical waste. We will also explore the relationship of the new rule to the Drug Enforcement Administration (DEA) disposal requirements under the Drug Disposal Rule of 2014. Finally, this session will introduce the concept of hazardous drugs from an OSHA perspective, and describe the pending USP <800> requirements facing healthcare facilities on December 1, 2019 and how they interface with hazardous waste regulations.
   Speakers
Charlotte Smith, WM Sustainability Services, Senior Regulatory Advisor csmith@pharmecology.com

Greg Blount, Troutman Sanders

   Presentation
BREAKING NEW GROUND: EPA'S FINAL HAZARDOUS WASTE PHARMACEUTICAL RULE
This session will compare and contrast the new hazardous waste pharmaceutical regulations with both the current EPA and California DTSC regulations as they apply to pharmaceutical waste. We will also explore the relationship of the new rule to the Drug Enforcement Administration (DEA) disposal requirements under the Drug Disposal Rule of 2014. Finally, this session will introduce the concept of hazardous drugs from an OSHA perspective, and describe the pending USP <800> requirements facing healthcare facilities on December 1, 2019 and how they interface with hazardous waste regulations. Presenter: Charlotte Smith
Implications for California, Reverse Distribution, and Reverse Logistics
History of Rule Relative to California Recap of Key Provisions Effective Date and State Implementation How Will Rule Potentially Dovetail with California Law How Will Rule Potentially Conflict with California Law Significance of Retail Strategy Guidance in Preamble Implications for Reverse Distribution and Reverse Logistics Path Forward