27: Pharmaceuticals and Medicine

New EPA Regulation Affects Healthcare Industry

July 10, 2019
Failure to comply can result in costly fines and puts individuals and the environment at risk.

The U.S. Environmental Protection Agency (EPA) recently published its highly anticipated final rule on the Management Standards for Hazardous Waste Pharmaceuticals.

This new regulation was published in the Federal Registrar in Feb. 22, 2019, and it requires health and environmental facilities to examine and likely restructure their hazardous waste management practices.

These new standards will replace current hazardous waste generator regulations, which is why it’s imperative for your facility to be aware of these changes in order to provide a safe and healthy work site.

While the final rule does not increase the number of pharmaceuticals considered to be hazardous waste, it does include many changes that will impact your work. Failure to comply can result in costly fines and puts individuals and the environment at risk. In fact, non-compliance fines levied against the sector have increased in recent years, resulting in significant monetary penalties against facilities that are non-compliant.

The new legislation was detailed in hundreds of pages. Below, we broke down what you need to know and how EHS professionals at large can help their sites stay safe and compliant when managing hazardous waste pharmaceuticals.

Key points

Under the new rule, health care facilities and reverse distributors will have to change how they currently handle, store, transport and dispose of hazardous waste. The new rule also:

  • Prohibits disposal down the drain
  • Eliminates dual regulations
  • Maintains take back exceptions
  • Amends nicotine listing
  • Organizes reverse logistics policy

Prohibits disposal down the drain

The new regulation prohibits the disposal of hazardous waste pharmaceuticals down the drain. Reducing intentional sewer disposal is one mechanism to help reduce the environmental loading of pharmaceuticals into our nation’s waters, according to the EPA.

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. This part of the rule is effective in all states on Aug. 21, 2019.

Eliminates dual regulations

The rule also eliminates the dual regulation of Resource Conservation & Recovery Act (RCRA) hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances. A part of this is providing regulatory clarity on how pharmaceuticals must be managed under the DEA, EPA and U.S. Food and Drug Administration (FDA).

Maintains take back exceptions

The rule maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take back programs and events, while ensuring their proper disposal.

A household product that contains hazardous substances becomes household hazardous waste once the consumer no longer has a use for it and disposes of it. This includes batteries, televisions, old paint, pesticides and unused or expired drugs.

Amends nicotine listing

The EPA edited the current listing for acutely hazardous nicotine and salts, designating that FDA-approved, over-the-counter nicotine replacement therapies such as patches, gums and lozenges will no longer be considered acutely hazardous waste.

Although over-the-counter nicotine replacement therapies are no longer considered hazardous when discarded, e-cigarettes are still considered an acute hazardous waste and are subject to the new requirements.

Organizes reverse logistics policy

Another key change provides regulatory clarity on how pharmaceuticals must be managed and establishes a policy on the regulatory status of unsold retail items that are not pharmaceuticals and are managed via reverse logistics. This is an important change, as California has taken enforcement actions against several national retail chains with pharmacies for not fully complying with the previously convoluted reverse distribution process.

The rule clarifies the regulatory status of a major practice used by the industry, and especially retailers and some manufacturers, for the management of unused drugs known as “reverse distribution.” This refers to the process of returning unused pharmaceuticals accumulated during the course of normal operations. During this process, drugs that are not dispensed are handed off to specialized brokers for disposal.

This final rule streamlines the practice by establishing standards for managing hazardous waste pharmaceuticals, reducing regulatory burden on facilities that house them and aligning with the existing practices of the industry.

Your next steps

State-by-state adoption of the Management Standards of Hazardous Waste Pharmaceuticals will be a long process with varying timelines and outcomes as states have the ability to be more stringent. The rule will go into effect in Alaska, Iowa and Puerto Rico on Aug. 21, 2019. Other states will have until 2021 or 2022 to adopt the new rule. This is because each state has their own version of the EPA and can adapt the rule accordingly.

EHS professionals are encouraged to seek help from a third-party vendor to not only help dispose of hazardous waste pharmaceuticals, but to also serve as a compliance expert. Turning to a trained professional can help ensure your facilities are up-to-date in regulatory changes. This can fulfill your mission of providing safe and healthy work sites for any industry.

For additional information visit the EPA website here.

Wade Scheel is the director of governmental affairs for Stericycle Environmental Solutions, a provider of environmental and regulated waste management solutions. Stericycle’s hazardous waste services support virtually any kind of business that generates hazardous waste. Learn more at www.stericycleenvironmental.com.

About the Author

Wade Scheel | Director of Governmental Affairs

Wade Scheel is the Director of Governmental Affairs for Stericycle Environmental Solutions, a leading provider of environmental and regulated waste management solutions. Stericycle’s hazardous waste services support virtually any kind of business that generates hazardous waste. Learn more at www.stericycleenvironmental.com.

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