Highlights of the EPA’s Newly Proposed Hazardous Waste Pharmaceutical Rule

Highlights of the EPA’s Newly Proposed Hazardous Waste Pharmaceutical Rule

The EPA has proposed regulations that will address the handling and disposal of hazardous pharmaceutical waste.  Many entities that provide pharmaceuticals, including over-the-counter drugs, often face difficulties when trying to determine how to properly dispose of returned, damaged or expired products.  As a result of their ingredients, a number of these drugs may be regulated as a hazardous waste under the Resource Conservation and Recovery Act (“RCRA”), which has onerous requirements for the handling and disposal of such waste.  The EPA proposal attempts to reform these requirements for pharmaceutical hazardous waste.  

The proposal applies to healthcare facilities, pharmaceutical reverse distributors, and entities that treat, store and dispose of hazardous waste pharmaceuticals.  The definition of a healthcare facility includes retail pharmacies and retail establishments that sell drugs, including over-the-counter drugs.  The proposal reduces the requirements of RCRA that many of these entities face when managing hazardous waste pharmaceuticals.  

The proposal distinguishes between pharmaceutical wastes that will be disposed of and those that will returned to a manufacturer for credit (reverse distribution or logistics), and sets up different standards for the handling of each.  The proposal also includes a complete ban on the disposal of any hazardous waste pharmaceutical to a sewer system that passes through to a publicly-owned treatment works and standards to determine when containers or syringes with hazardous waste pharmaceutical residue can be managed as a non-hazardous waste.  

Businesses that handle hazardous waste pharmaceuticals should continue to follow the progress of this EPA proposal.  For many, the proposal will provide much needed clarity and reform to the proper management and handling of these types of wastes.