Pharmaceutical and Retail Waste Compliance and Enforcement

The consumer products industry is subject to innumerable regulation at the federal and state levels. In particular, the Environmental Protection Agency (EPA) and state authorities continue to bring significant enforcement actions across the United States regarding proper handling, transportation and disposal of pharmaceutical and hazardous wastes.

The implications of pharmaceutical waste management are far ranging and changes in the requirements can have a substantial impact on supply-chain logistics. With an increased focus on potential environmental impacts of pharmaceutical waste disposal, federal and state officials have become increasingly aggressive in inspecting businesses that dispense pharmaceuticals and taking enforcement action for alleged violations of the hazardous waste regulations.

Additional significant hazardous-waste management requirements are imposed by the following:

  • The Resource Conservation and Recovery Act (RCRA) and state counterparts
  • The Pipeline and Hazardous Materials Safety Act (PHMSA)
  • The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
  • The Clean Air Act (CAA)
  • The Clean Water Act (CWA)

Troutman Sanders has a dedicated team of attorneys that has been on the cutting edge of pharmaceutical waste and consumer product regulation issues since 2009. Drawing on our broad experience across the United States and several EPA regions, we provide an integrated approach to advising manufacturers, distributors and retailers of consumer products.

We are the national environmental counsel for a Fortune 20 retail pharmacy and have addressed retail and pharmaceutical waste (e.g., RCRA, CWA, hazardous material business plan (HMBP)) inspection issues and enforcement in approximately 30 states. We also provide environmental counsel for a large regional grocery chain with a significant presence throughout the western United States. We have helped build retail and pharmaceutical waste programs from the ground up and incorporated elements of these programs into consent judgments in a number of states.

In California, a state at the forefront of these issues, we are engaged with the Department of Toxic Substances Control (DTSC), the California Department of Public Health (CDPH), and other key stakeholders on needed regulatory reform. We represented a retail pharmacy through settlement with the California District Attorneys with respect to hazardous waste compliance issues, which included compliance under the Medical Waste Management Act, as well as ongoing compliance advice under federal and California laws. We also work with U.S. EPA and large trade associations on federal regulatory reform to help policymakers grapple with how best to manage pharmaceutical waste, now and in the future.

Our objective is to develop a practical and consistent regulatory framework that provides for responsible, streamlined disposition of pharmaceutical and retail wastes and materials.

  • Represented a Fortune 20 retail pharmacy as national environmental counsel in connection with significant enforcement actions in California and Connecticut that related to alleged noncompliance with hazardous waste management and wastewater discharge requirements. The California case settled in 2012 and the Connecticut settlement was finalized in January 2013. The Connecticut consent order fashioned a first-of-a-kind best management practice for the reverse distribution of pharmaceutical waste in lieu of strict application of state hazardous waste requirements. This order also crafted novel hazardous waste container storage area closure requirements applicable to the retail setting.
  • Represented a Fortune 20 retail pharmacy before U.S. EPA and states as regulatory reform is considered to address national retail waste issues. This representation and work was cited in a recent decision by U.S. EPA Region V to exercise its enforcement discretion to not seek penalties or enforcement for historical compliance issues with pharmaceutical waste management and reverse distribution of pharmaceuticals.
  • Represented a national grocery chain as environmental counsel in connection with inspections and enforcement in California; and advised a grocer on matters related to compliance with hazardous waste management standards and associated training requirements.
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