The final rule for the Environmental Protection Agency’s (EPA) Management Standards for Hazardous Waste Pharmaceuticals was released in the Federal Register on Feb. 22, 2019, and outlines a new set of sector-specific standards in lieu of the existing hazardous waste generator regulations. The final rule goes into effect Aug. 21, 2019, and it does not apply to pharmaceutical manufacturers (unless they act as reverse distributors) or production facilities.
Among other things, the new regulation prohibits the disposal of hazardous waste pharmaceuticals down the drain and eliminates the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances. Reducing intentional sewer disposal is one mechanism to help reduce the environmental loading of pharmaceuticals into our nation’s waters.
While effective dates to adopt the rule may vary by state, the exception to state adoption is the ban on flushing pharmaceuticals down the toilet, rinsing them the sink or other “sewering” methods, which is effective in all states on Aug. 21, 2019.
The rule also now mandates that LTC facilities be included in the requirements set out by the new rule regarding the generation, management, storage, treatment and disposal of hazardous waste pharmaceuticals. While the final rule does not increase the number of pharmaceuticals considered to be hazardous waste, it does include many changes that will impact LTC and healthcare facilities.
While the new legislation was detailed in hundreds of pages, here is a summary, along with highlights on how the final rule’s regulations may affect healthcare facilities.
Key highlights include:
- The rule maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take back programs and events, while ensuring their proper disposal.
- Provides regulatory clarity on how pharmaceuticals must be managed under the DEA, EPA and U.S. Food and Drug Administration (FDA). The new regulations eliminate the dual regulation of RCRA hazardous waste pharmaceuticals that are also DEA controlled substances.
- Offers regulatory relief to healthcare facilities for management of hazardous waste pharmaceuticals: Does not count toward generator status, eases labeling and manifesting and clarifies wastes to be shipped to reverse distributors.
- Amends the listing of nicotine patches, gums and lozenges so they no longer have to be managed as hazardous waste. The EPA is excluding certain FDA-approved over-the-counter nicotine replacement therapies from regulation as hazardous waste.
- Establishes a policy on the regulatory status of unsold retail items that are not pharmaceuticals and are managed via reverse logistics.