Healthcare entities are facing several changes when it comes to managing pharmaceuticals considered to be hazardous waste under the Resource Conservation and Recovery Act (RCRA). These entities include hospitals, pharmacies, dentists, nursing and long-term care (LTC) facilities, as well as clinics and reverse distributors.

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.

Summary of changes:

Small and Large Quantity Generators (SQG and LQGs) that meet the EPA’s new definition of a healthcare facility or reverse distributor must manage their hazardous pharmaceutical waste under new subpart P.

Additionally, Very Small Quantity Generators (VSQGs) that meet the EPA’s new definition of healthcare facility or reverse distributor have the option of managing hazardous pharmaceutical waste under new subpart P.

Facilities have less stringent options to dispose of containers with residual hazardous waste and P-listed wastes. P-listed wastes include chemicals that are either 100% pure, technical grade or the sole active ingredient in a chemical formulation.

Impact on generator status:

Under the new final rule, pharmaceutical waste (including P-listed wastes) will not count toward generator status. Hazardous waste from other areas of healthcare facilities and reverse distributors, such as solvents and other non-pharmaceutical waste – such as products or other retail waste – will still be used to determine generator status.

More information on the categories of hazardous waste generators and their requirements can be found on the EPA’s website.

Nicotine waste:

As mentioned above, under this final rule, the EPA edited the current listing for acutely hazardous nicotine and salts (P075), designating that FDA-approved, over-the-counter nicotine replacement therapies such as patches, gums and lozenges will no longer be considered acutely hazardous waste.

This new exception applies to all generators of hazardous waste, not just healthcare facilities as it is outside of subpart P. Other nicotine containing products such as prescription replacement therapies and e-cigarettes are not excluded from the P075 listing and would still be regulated as such.

Next steps:

Though these are final regulations, the current rules remain in effect until the effective date in the federal register and states adopt them. It is very important to understand that all current RCRA regulations are being enforced. It is recommended that facilities potentially impacted by the final rule review the regulations and begin planning for the changes to take effect.


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