Pharmaceutical Waste Management: Compliance for Hospitals, Pharmacies, and Other Healthcare Facilities

Leveraging Recent Environmental Enforcement Actions and Understanding Policy Shifts to Ensure Regulatory Compliance

Recording of a 90-minute CLE webinar with Q&A


Conducted on Thursday, July 30, 2015

Recorded event now available

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Program Materials

This CLE webinar will provide guidance for counsel to healthcare facilities on structuring and implementing pharmaceutical waste management practices to ensure compliance with federal and state laws. The panel will examine recent enforcement actions and the practical lessons for health and environmental counsel.

Description

Healthcare facilities, from hospitals to big box retailers with pharmacies, and their pharmaceutical waste management practices have become the focus of EPA and state enforcement actions. Therefore, it is critical for healthcare facilities and their counsel to fully understand the regulatory requirements and implement effective compliance programs across various jurisdictions.

Federal and state laws and regulations, including Resource Conservation and Recovery Act (RCRA), the Clean Water Act, and state medical waste management laws govern pharmaceutical waste management practices. These requirements apply to all entities that manage pharmaceuticals, including hospitals, physician practices, pharmacies, nursing homes, and grocery chains with pharmacies. Healthcare facilities can struggle to integrate environmental requirements with the myriad of other non-environmental regulations confronting these facilities.

Failing to comply can result in significant penalties. For example, in Jan. 2015, a retail chain agreed to pay penalties of almost $10 million for improper disposal of hazardous and medical waste. Having a plan in place to address proper handling, storage and disposal of pharmaceuticals is essential to minimize the risk of penalties and other sanctions.

Listen as our authoritative panel examines the recent enforcement actions against hospitals, pharmacies, ambulatory surgery centers, big box retailers and other healthcare providers that have pharmacies, and as the panel discusses the lessons that can be drawn from these enforcement actions. The panel will provide guidance for structuring and implementing pharmaceutical waste management practices to ensure compliance with federal and state laws.

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Outline

  1. Laws and regulations governing pharmaceutical waste management
    1. RCRA
    2. Clean Water Act
    3. Controlled Substances Act
    4. State statutes
  2. Recent enforcement actions and lessons from them
  3. Pharmaceutical waste management programs to ensure compliance
    1. Structuring program
    2. Identification of hazardous waste
    3. Determination of generator status
    4. Recordkeeping and reporting requirements
    5. Accounting for state variations
  4. How to plan for federal reform and state policy deviations

Benefits

The panel will review these and other key questions:

  • What challenges do hospitals, retail pharmacies and other healthcare entities face as a result of the increased environmental enforcement?
  • What lessons can be learned from what other healthcare facilities did or did not do in their pharmaceutical waste management?
  • What steps should healthcare entities take to ensure compliance with EPA and state regulations in the disposal of pharmaceuticals?

Faculty

Gregory W. Blount
Gregory W. Blount

Partner
Troutman Sanders

Mr. Blount has broad experience representing clients in matters related to environmental law and policy for over 30...  |  Read More

Charlotte A. Smith
Charlotte A. Smith
Senior Regulatory Advisor
WMSS PharmEcology Services

Ms. Smith founded PharmEcology Associates, LLC in 2000 and sold the company to Waste Management in 2009. She...  |  Read More

Darrell J. Oman
Darrell J. Oman
Program Manager – Consulting Services
Stericycle Environmental Solutions

Mr. Oman has over 30 years of consulting and management experience in the Environmental, Health and Safety...  |  Read More

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