April 07, 2020

Unpacking the EPA’s Final Hazardous Pharmaceutical Waste Management Rule

Digging in to the New EPA Final Rule

To ensure compliance with the Environmental Protection Agency’s (EPA) new hazardous pharmaceutical waste management rule, health care organizations that are small or large quantity generators should familiarize themselves with the regulations and work to understand how they apply to specific settings.

Very small quantity generators (VSQG) have the option to follow the rule.

To help organizations better appreciate the rule’s scope and impact, the following sections continue our discussion  of some of the key elements.

Determining Waste Generator Status

Under the new rule, pharmaceutical waste (including P-listed waste) will no longer count toward an organization’s waste generator status. In other words, it will not impact whether a facility is deemed to be a very small, small or large quantity generator.

Note that other hazardous waste, such as solvents and non-pharmaceutical items, will still be used to determine generator status. The EPA requires that any waste characterization tests and reports be kept for a period of three years from the date they are performed.

Flushing Drugs Is Not Allowed

One of the most notable requirements of the new rule relates to the flushing of hazardous pharmaceuticals—something that has been linked to negative environmental ramifications. The Final Rule bans hazardous drug flushing regardless of generator type. The ban does not affect non-hazardous pharmaceuticals, or controlled substances which fall under Drug Enforcement Administration (DEA) regulations.

Distinguishing Between Potentially Creditable and Non-Creditable Hazardous Waste Pharmaceuticals:

The EPA rule created two distinct categories of hazardous pharmaceutical waste and has set criteria for which drug waste falls into each category.

  1. Potentially Creditable Hazardous Waste Pharmaceutical—items which can be returned to a reverse distributor for possible credit and are:
    1. In original manufacturer packaging (except pharmaceuticals that were subject to a recall)
    2. Undispensed
    3. Unexpired or less than one year past expiration date
  2. Non-Creditable Hazardous Waste Pharmaceutical—items which can’t be sent back

Selecting the Appropriate Containers

The rule addresses hazardous pharmaceutical waste storage, eliminating satellite and central accumulation area requirements and replacing them with container requirements. Health care organizations can accumulate hazardous pharmaceutical waste for one year as long as it is housed in the proper container, while reverse distributors have shorter timeframe requirements.

Containers must be in good condition and free of rust, structural defects and deterioration. Organizations must periodically check that the containers are not damaged or leaking, resulting in the release of waste into the environment. Clear labeling is also important and must include the words, “Hazardous Waste Pharmaceuticals.”

Although the EPA is not overly prescriptive about storage area characteristics, it does suggest organizations ensure the general public cannot access the containers and that facilities use locks to keep unauthorized personnel out.

Providing Comprehensive Training

Now that the regulations provide clarity around health care requirements, it is imperative that organization staff understand what’s new and how the rule will affect their day-to-day tasks.

The regulations require that any employee generating, managing or interacting with hazardous pharmaceutical waste be trained on proper handling and emergency procedures. Online training modules and/or continuing education within staff meetings could suffice in meeting these recommendations.

Take Time to Prepare

Although the new rule has been finalized, it will not go into effect until 6 months from the date of publication. Organizations should spend this time getting up to speed on the regulations’ nuances and preparing for compliance. Here are some further resources to help with this effort, and keep an eye out for our upcoming webinar on the topic for even more information.

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