EPA's Final Rule: Management Standard for Pharmaceuticals

The EPA Acting Administrator signed the final rule, titled, "Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine" on December 11, 2018 and it was published in the Federal Register (FR) on February 22, 2019.

This final rule establishes cost- saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.

Importantly, this final rule will make our drinking and surface water safer and healthier by reducing the amount of hazardous waste pharmaceuticals entering our waterways by 1,644 to 2,300 tons on an annual basis by prohibiting all facilities subject to the rule from sewering them. This action will help address the issue highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.

In addition, under this final rule, FDA-approved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded, which will result in significant cost savings and burden reduction in the management of these types of nicotine wastes.

Finally, the final rule reaffirms EPA's long-standing policy that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste. It also provides regulatory certainty that the Resource Conservation and Recovery Act (RCRA) applies when healthcare facilities send unused, unsaleable prescription hazardous waste pharmaceuticals to reverse distributors to receive manufacturer credit. Simultaneously, the rule incorporates flexibilities to accommodate current reverse distribution business practices to facilitate its implementation.

[Go to the EPA's website on the final rule]




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