- Under a new rule from the Environmental Protection Agency (EPA), prescription pharmaceuticals sent from healthcare facilities to reverse distributors will be regulated as solid waste and must be evaluated for hazardous classification at the healthcare facility.
- Those facilities and reverse distributors that dispose of prescription pharmaceuticals must register with the EPA, and separate prescription and characteristically hazardous products from non-prescription products.
- The EPA says the new rule was designed to reduce the amount of hazardous waste entering drinking and surface water from people discarding pharmaceuticals by "sewering," or flushing them down sinks and toilets.
The new rule finalizes EPA policy discussions dating back to the 1980s about how to handle pharmaceuticals being discarded or returned from healthcare facilities.
Previously, pharmaceuticals in the reverse supply chain were not considered waste until a determination was made the products should be discarded. Healthcare facilities relied on reverse distributors to determine whether products should be discarded or could be returned for credit or reuse.
Under the new rule, when pharmaceuticals are designated as being discarded, they become solid waste, which triggers management obligations under the Resource Conservation and Restoration Act (RCRA) for pharmaceuticals that are toxic or meet the definition of certain "listed" wastes.
"That change will create significant regulatory uncertainty, and potential liability, for entities in the pharmaceutical distribution chain that suddenly find themselves evaluating compliance with the new rule," attorneys for the Foley & Lardner law firm wrote in a company blog post.
For non-prescription pharmaceuticals, EPA will continue to allow healthcare providers to ship potentially reusable and reclaimable over-the-counter drugs and dietary supplements as recyclable products not covered under the RCRA waste regulations to reverse distributors, where the actual decision to reuse/reclaim or discard the material will be made.
The EPA said the new procedures would make drinking and surface water safer and healthier by reducing the amount of hazardous waste pharmaceuticals entering waterways by 1,644 to 2,300 tons each year. A number of studies have documented the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems, the EPA said.
EPA Acting Administrator Andrew Wheeler signed the final rule Dec. 11. It goes into effect six months after that date, barring any legal challenges.