January 18, 2021

What to Know: EPA Final Rule on Management of Hazardous Waste Pharmaceuticals

Meeting the Environmental Protection Agency’s (EPA) requirements for hazardous pharmaceutical waste disposal can be challenging for healthcare organizations, especially for hospitals and health systems. The following sections are designed to provide clarity about the new regulations and strategies to ensure your organization remains compliant.

What Is the EPA Final Rule on Management of Hazardous Waste Pharmaceuticals?

The EPA’s Final Rule on Management of Hazardous Waste Pharmaceuticals is a subsection of the Resource Conservation and Recovery Act (RCRA). Frequently referred to as Subpart P, it covers how healthcare organizations can safely dispose of hazardous pharmaceutical waste.

Although the EPA has enforced rules governing hazardous waste since 1976, healthcare facilities have long struggled with compliance because the rules mostly focused on industrial waste generators, resulting in some confusion on how the requirements are applicable to healthcare settings. Subpart P provides standards that better align with healthcare facility operations, making them easier to understand and follow.

How Does Subpart P Benefit the Environment?

Overall, Subpart P helps keep dangerous pharmaceuticals out of waterways and land areas. One of the rule’s major components prohibits healthcare facilities from flushing pharmaceuticals down the toilet or drain.

Also known as sewering, this practice can have a severe impact on surrounding ecosystems because typical waste treatment processes do not remove hazardous drug residue from wastewater. Although scientists do not fully understand the long-term effects of trace pharmaceuticals on humans, there have already been concerning effects on fish and wildlife that point to possible ways these pollutants could harm people. By banning sewering, the EPA hopes to prevent thousands of tons of hazardous waste pharmaceuticals from passing into the environment.

The Subpart P sewering ban went into effect in all states on August 21, 2019 and applies to all waste generators. Even though it regulates hazardous pharmaceuticals specifically, it also strongly discourages the flushing of any pharmaceuticals, including over the counter medications.

Categories of Hazardous Waste Pharmaceuticals

The EPA delineates three categories of hazardous waste pharmaceuticals in Subpart P:

  1. Potentially creditable hazardous waste pharmaceuticals.

These are medications that have a reasonable expectation of being returned to a reverse distributor for possible credit. They must be in the original manufacturer packaging, undispensed, and unexpired, or less than one year past their expiration date. 

  1. Evaluated hazardous waste pharmaceuticals.

These pharmaceuticals have been evaluated by a reverse distributor and will not be sent to another reverse distributor for further evaluation or credit.

  1. Non-creditable hazardous waste pharmaceuticals.

These pharmaceuticals cannot be sent back to a reverse distributor because there is not a reasonable expectation of receiving credit. These items are to be disposed of by the generator as hazardous waste pharmaceuticals. The disposal process is governed by Subpart P.

Hazardous Waste Pharmaceutical Containers and Subpart P

Container use and storage is another important topic covered by Subpart P, with the rule emphasizing the importance of safety and security.

Organizations may opt to store pharmaceutical waste containers near the point of drug administration, and/or in a central accumulation area. Regardless of the storage location, entities can only store the waste for a year. Storage containers must be:

  • Labeled with the words “hazardous waste pharmaceuticals”.
  • Closed at all times.
  • Kept in good condition.
  • Secured in a manner that prevents unauthorized access.
  • Compatible with the waste it contains.

Who Is Affected by the EPA Final Rule Subpart P?

Subpart P covers most healthcare entities that manage pharmaceutical products and waste, including hospitals, pharmacies, clinics, dental practices, skilled nursing facilities, and long-term care organizations as well as reverse distributors. The regulations do not pertain to pharmaceutical manufacturers (unless they act as reverse distributors) or production facilities.

Healthcare organizations that are small quantity (SQGs) or large quantity generators (LQGs) of hazardous waste must comply with Subpart P. Very small quantity generators (VSQGs), formerly known as conditionally exempt small quantity generators (CESQ), are not required to follow Subpart P, except for the sewer ban, which applies to all generators. Small- and large-quantity waste generators must notify the EPA that they are following the rule within 60 days of it becoming law in their state.

To make sure you meet the EPA requirements, review and understand your current hazardous waste generator status so you can know if the rule applies to your facility when it goes into effect in your state. Be aware that under Subpart P, none of the hazardous waste pharmaceuticals that are disposed will contribute to your waste generator status.

When Is My Organization Required to Comply with the EPA Final Rule Subpart P?

The rule went into effect at the federal level on August 21, 2019. Some states have already adopted and are enforcing it while others are still in the review and implementation phases. As states adopt the regulations, they can make changes; these changes cannot be less stringent than the rule but can be more stringent.

Although all states have adopted the sewer ban, effective dates vary from state to state as they have until July 1, 2021, or July 1, 2022, to adopt the other aspects of the rule, depending on their legislative process. To check the status of adoption in your state, view the EPA’s map of where Subpart P is in effect.

What Is the Amendment to the P075 listing for Nicotine?

While nicotine and empty containers that hold nicotine products are considered P-listed waste, the EPA no longer considers FDA-approved, over-the-counter nicotine replacement therapies, such as patches, gums and lozenges, as P-listed hazardous waste (P075) when they are discarded. The amendment does not apply to prescription nicotine therapies or e-cigarette products.

This modification of the P-listed waste rules applies to any hazardous waste generator, not just healthcare organizations. Since this exception is more lenient than the current law, states do not have to adopt it, and there is no set timeline for adoption. As such, it’s important to be aware of what your state specifically requires.

For more information on EPA Final Rule Subpart P, visit our EPA Final Rule hub. For information about how Stericycle can help you safely and compliantly dispose of hazardous pharmaceutical waste, visit our Pharmaceutical Waste Services page.

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