Pharmaceuticals in Reverse Supply Chain Now Hazardous Waste

A new rule finalized by the Environmental Protection Agency (EPA) requires that prescription pharmaceuticals sent from healthcare facilities to reverse distributors must be regulated as solid waste and evaluated for hazardous classification at the healthcare facility before they are shipped.

First proposed four years ago, the final rule was signed in December 2018 by EPA Acting Administrator Andrew Wheeler and is expected to become effective in June. “This rule will impose significant new obligations on healthcare providers, including pharmacies and long-term care providers, as well as forward and reverse distributors of pharmaceuticals,” state attorneys for the law firm of Foley & Lardner.

In the 1980s and 1990s, EPA’s position in policy memoranda was that pharmaceuticals in the reverse distribution chain were “not considered wastes until a determination has been made to discard them.” That approach worked well for healthcare providers, who frequently relied on reverse distributors to determine whether their unused prescription and over-the-counter medications could be credited/reused/reclaimed or should be discarded, the lawyers note.

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