The Environmental Protection Agency’s new rule regarding disposal of hazardous pharmaceutical waste takes effect in August 2019. As we noted previously (in Part 2 of this series of articles), the rule is intended to improve how pharmaceutical waste is managed by the health care sector, to better protect humans and the environment.
Our Part 1 of this three-part series, shared some basic information about the new rule. In Part 2, we explained why the new rules were created and what the term “hazardous pharmaceuticals” actually means under the new rule. Here, in Part 3, we discuss who is affected by the new rule and the penalty for non-compliance.
What’s a Health Care Facility under the EPA Rule?
The EPA stated that the purpose of the new rule is to streamline standards for managing hazardous waste pharmaceuticals in the health care sector. That sounds like it might make things easier in your workplace, but who is affected by the rule? The simple answer is “healthcare facilities and reverse distributors”, but what does the term “healthcare facilities” include?
It’s a broad definition. If anyone in your facility is lawfully authorized to do any of the following, you’re a healthcare facility:
- provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or
- distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals.
Some entities may not realize they are affected, such as long-term care facilities, chiropractors, ambulance services, as well as wholesale distributors, third-party logistics providers that act as forward distributors and military medical logistics facilities. That’s right – some facilities that do not treat or even see patients are covered by the rule because they handle pharmaceuticals and therefore can generate pharmaceutical waste.
The new standards do make things easier for health care facilities, compared to the hazardous waste generator regulations that apply to pharmaceutical manufacturers. Under the new EPA rule, a healthcare facility:
- will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations;
- will not become a Large Quantity Generator, with all of the associated requirements, if it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
- will not have to comply with the regulations affecting satellite accumulation areas (these regs have not been a good fit for healthcare facilities); and
- will not need to specify hazardous waste codes on manifests;
What about reverse distributors?
The EPA rule also applies to reverse distributors, defined as any person that receives and accumulates potentially hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. This includes entities such as forward distributors, third-party logistics providers, and pharmaceutical manufacturers that process prescription pharmaceuticals to facilitate or verify manufacturer credit. As noted above, even though these entities never see patients, they are affected because they can generate pharmaceutical waste.
What is the penalty for violating the rules?
The maximum civil penalty for violating the EPA's RCRA hazardous waste storage, management, and disposal requirements is now $72,718 per day, per violation. The new EPA pharmaceutical waste rule makes things easier for many facilities but it still provides clear boundaries, so be sure you stay within them.
United Medical Waste Management helps health-care facilities manage their hazardous waste from cradle-to-grave, in complete compliance with the regulations. Contact us for a free waste audit and facility evaluation.