Managing Waste Pharmaceuticals: New Obligations on Healthcare Providers, Expanded Definition of Healthcare Facility

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

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Conducted on Wednesday, June 19, 2019

Recorded event now available

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Course Materials

This CLE course will guide counsel to healthcare facilities on the new EPA rule on managing and disposing of unused or waste pharmaceuticals. The panel will discuss how the new rule changes the landscape and the steps to be taken to structure and implement practices for the management of unused or waste pharmaceuticals to ensure compliance with federal and state laws.


A new rule governing the management and disposal of unused pharmaceuticals goes into effect on Aug. 22, 2019. The rule expands the definition of healthcare facility as well as several other new definitions that impact the healthcare industry. For example, certain long term care facilities must now comply with the pharmaceutical rule and will no longer enjoy the household waste exclusion.

The fundamental change regarding when a pharmaceutical product is considered solid waste creates new obligations as well as regulatory uncertainty. Counsel to healthcare providers, from doctor and dental offices to hospitals to big-box pharmacies, as well as others in the pharmaceutical distribution chain, must understand the changes to the rule and the new compliance requirements and implement compliance practices.

Failing to comply can result in significant penalties. In Feb. 2019, the EPA increased the penalty amounts for a civil violation of environmental laws and regulations. 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 new rule (both requirements and penalties for noncompliance), how it changes the landscape from the current practice, and the steps healthcare providers and pharmaceutical distributors need to take to ensure compliance with the new rule.



  1. New EPA rule management and disposal of unused or waste pharmaceuticals
    1. Requirements
    2. Expanded definition of healthcare facility
    3. Penalties for noncompliance
  2. Changes from current practice
  3. Steps to ensure compliance


The panel will review these and other vital questions:

  • How does the new rule differ from the current rule and practices?
  • What does the expanded scope of healthcare facility mean for compliance with the new rule?
  • What steps should healthcare providers and facilities take to ensure compliance in the disposal of pharmaceuticals?


Keyes Fleming, Gwen
Gwendolyn Keyes Fleming

Van Ness Feldman

Ms. Keyes Fleming focuses on environmental policy, enforcement defense litigation, and special investigations for...  |  Read More

Palumbo, Marlys
Marlys Palumbo

Van Ness Feldman

Ms. Palumbo focuses on matters arising under major federal and state environmental, energy, and natural resources...  |  Read More

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