EPA Hazardous Pharmaceuticals Rule and USP 800 Webinar

Add to Calendar 01/22/2020 19:00 01/22/2020 20:00 EPA Hazardous Pharmaceuticals Rule and USP 800 Webinar With the publication of the EPA’s hazardous waste pharmaceuticals final rule in February, 2019, aging services providers suddenly found themselves trying to navigate an entirely new regulatory structure.  Fortunately, only a small portion of that rule has yet to become enforceable in Pennsylvania.  Now a little known set of standards finalized in 2016 by the United States Pharmacopeial Convention (USP), known as USP Chapter 800, has introduced comprehensive and often costly measures designed to promote safe handling of hazardous drugs.  This webinar will delve into the requirements of both the EPA rule and USP 800, discuss areas in which the two overlap, and examine the likely enforcement structure of USP 800. The presenters for this webinar will be Jennifer Hilliard, Esq. and Robert Durkin from Arnall Golden Gregory LLP. NHA/PCHA: This program has been approved for Continuing Education for 1.0 total participant hours by NAB/NCERS. Approval# 20210121-1-A62773-DL.This webinar is free to LeadingAge PA members. Non-members must pay a fee of $70. To receive continuing education credit for LeadingAge PA sponsored webinars, attendees must register under their own name, participate through the link supplied after registering, and complete the evaluation after the webinar.

EPA Hazardous Pharmaceuticals Rule and USP 800 Webinar

January 22 - January 22, 2020

Overview

With the publication of the EPA’s hazardous waste pharmaceuticals final rule in February, 2019, aging services providers suddenly found themselves trying to navigate an entirely new regulatory structure.  Fortunately, only a small portion of that rule has yet to become enforceable in Pennsylvania.  Now a little known set of standards finalized in 2016 by the United States Pharmacopeial Convention (USP), known as USP Chapter 800, has introduced comprehensive and often costly measures designed to promote safe handling of hazardous drugs.  This webinar will delve into the requirements of both the EPA rule and USP 800, discuss areas in which the two overlap, and examine the likely enforcement structure of USP 800. 

Speakers

Jennifer Hilliard
Of Counsel
Ms. Hilliard focuses her practice on long-term care and aging services issues generally. She has extensive experience with nursing home regulatory matters, compliance and operations. Additionally, she has significant experience with Federal public policy and government affairs in such related areas as Medicare and Medicaid regulation, home health and hospice regulation, DEA controlled substances regulation, OSHA and other labor and employment issues affecting aging services providers, and federal non-profit tax issues. Prior to joining AGG, Ms. Hilliard served for over 18 years in a variety of legal and advocacy-related capacities at LeadingAge, a Washington, DC based trade association for non-profit long-term care and aging services providers.
Robert Durkin
Of Counsel
Bob Durkin joins AGG as of counsel in the firm’s FDA and Healthcare practices, and is a member of the Dietary Supplements industry team. As a former acting Director and Deputy Director of the Office of Dietary Supplement Programs (ODSP) in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), he brings a wealth of knowledge and insight to his legal practice. In working with AGG clients, Bob will draw from the extensive experience he gained at the FDA where he was responsible for performing policy analysis and evaluations related to all aspects of the agency’s dietary supplement programs while also providing skillful advice on compliance and enforcement issues (such as Warning Letters, seizures, injunctions, import detention/refusal, etc.). During this time, he was active in a variety of agency working groups, including: Agency-wide Marijuana Working Group, Agency-wide CBD Policy Working Group, and the Agency-wide Investigational New Drug (IND) Policy Working Group. While helping to lead ODSP, Bob also successfully led the Office through multiple Government Accountability Office (GAO) investigations.

Just prior to joining ODSP, Bob was the acting Director of CFSAN’s Food Defense Staff. In this role, Bob led a dedicated group of professionals whose duty it was to determine the best regulatory strategies to help protect our nation’s food supply from intentional contamination. The Food Defense staff’s work includes the implantation of the Food Safety and Modernization Act’s Rule for Mitigation Strategies to Protect Food against Intentional Adulteration and determining the best ways to educate, and then regulate, industry relative to the Rule.

Bob has also served in both the Commissioner’s office and the Center for Drug Evaluation and Research (CDER). While in the Commissioner’s Office, Bob managed a staff of Emergency Response Coordinators whose focus was on coordinating an over-all Agency approach to mitigate and respond to urgent health concerns related to FDA regulated commodities. While at CDER, Bob worked in the areas of health fraud, over the counter drugs, and pharmacy compounding.

CEU Info

NHA/PCHA: This program has been approved for Continuing Education for 1.0 total participant hours by NAB/NCERS. Approval# 20210121-1-A62773-DL.

To receive continuing education credit for LeadingAge PA sponsored webinars, attendees must register under their own name, participate through the link supplied after registering, and complete the evaluation after the webinar.

Registration

This webinar is free to LeadingAge PA members. Non-members must pay a fee of $70. 

All educational programs are provided by the LeadingAge PA Foundation. 

Premier Sponsors