Challenges in Pharmaceutical Waste Management: “First, Do No Harm”

Vol. 26 No. 4

Mr. Johnson and Mr. Blount are partners, and Ms. Clemons and Ms. Williams are associates in the Environmental and Natural Resources Practice Group of Troutman Sanders LLP.

The regulated community and policymakers are grappling with how best to manage pharmaceutical waste, now and in the future. In some ways, they may best be guided by the Hippocratic admonition: Do no harm. Otherwise, unintended consequences could interfere with the vital flow of medication to and from dispensing facilities. Pharmaceutical waste management presents major challenges for hospitals, clinics, physicians’ offices, and retail pharmacies. The implications of pharmaceutical waste management are far ranging and changes in the requirements can substantially impact pharmaceutical 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. For instance, in 2009, a hospital agreed to pay the U.S. Environmental Protection Agency (EPA), Region 7, $51,501 in civil penalties, and agreed to spend nearly $500,000 on a plan to manage pharmaceutical and other wastes. That same year, a California court assessed a civil penalty totaling $8,650,000 against a national retail company for alleged hazardous waste violations, including mismanagement of pharmaceutical waste.

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