Many Americans have the impression that our government is a slow-moving, encumbered behemoth, with a penchant for complicating what should be simple issues.

Thankfully, a recent final ruling from the EPA does exactly the opposite of that.

Published in the Federal Register back in February, the ruling is taking what was the complex and ill-fitted process of hazardous pharmaceutical waste disposal by healthcare facilities and reverse distributors and replacing it with an attuned, streamlined framework. While promising and exciting, these new regulations inevitably incur a variety of questions and concerns, especially by those entities who are affected by the legislation concerning hazardous waste disposal.

Along that vein of thinking (and process), our team decided we’d take the list of frequently asked questions from the EPA site and condense it into an understandable, bite-sized list of the most important points and provisions.

Before we get started, we must make our obligatory disclaimer: While this list does cover many of the topics addressed in the legislature, it is by no means meant to be used as a comprehensive reference text nor a legal document. (We figured you wouldn’t, but we still had to tell you)

With that being said, let’s dive into the changes the EPA is rolling out in “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” ruling:

#1 – Why is this being passed?

  • Healthcare facilities and reverse distributors have struggled to implement and maintain the industry-focused RCRA regulations for hazardous pharmaceutical waste
  • Pharmaceuticals and their metabolites have been entering ground and surface water systems, polluting and disrupting vital aquatic ecosystems

#2 – How does this help the environment?

It decreases the risks and impact resulting from drugs being flushed down the drain. Previously, this had been one of the approved and standardized means of hazardous pharmaceutical waste disposal.

The law aims — in part — to prevent the flushing of approximately 1644 to 2300 tons of hazardous pharmaceutical waste disposal per year.

It also seeks to stop the diversion of discarded pharmaceuticals into the black market, which typically takes place during the transport of hazardous pharmaceutical waste disposal from the generator to the reverse distribution centers.

Additionally, this ruling eliminates the dual regulation of hazardous scheduled drugs by the DEA and the EPA.

#3 – Who is this for?

This ruling and its accompanying legislature is custom-made for, and applicable to “healthcare facilities” and “reverse distribution centers.” It stipulates the characteristics that a business entity must possess in order to be designated as such.

This does NOT apply to pharmaceutical manufacturers or related industries, unless they meet the criteria designating one of the above labels.

OTC nicotine replacement therapies are not included in this ruling, as they possess their own set of regulations.

#4 – What defines a healthcare facility?

Any entity who is legally permitted to:

  1. Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care and counseling services, assessments, or procedures 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
  2. Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals.

#5 – What defines a reverse distributor?

Any entity that:

Receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.

#6 – What defines a pharmaceutical?

A pharmaceutical is stipulated as:

Any drug, dietary supplement, electronic nicotine delivery system, or packaged liquid nicotine. Includes dietary supplements, prescription, OTC, homeopathic, compounded, or investigational drugs, non-empty pharmaceutical containers, contaminated PPE, and cleanup material from spills of any of these materials

*Sharps and dental amalgams are exempted*

#7 – What pharmaceuticals does this apply to?

Any pharmaceutical that possesses the defining characteristics of a hazardous waste as described in 40 CFR §261. This means that the hazardous pharmaceutical has:

  1. An entry on either the P or U lists (of which there are approximately 30 such compounds). This is structure-specific, and does not waiver from brand to brand. For example, lindane, Gammallin, and (1r,2R,3S,4r,5R,6S)-1,2,3,4,5,6-hexachlorocyclohexane, while all possessing very different monikers, are the same compound with the same CAS # [58-89-9].
  2. One or more of the aspects or chemical species requiring designation as a “Characteristic Waste”’. The characteristics that imbue a “hazardous” label for a pharmaceutical waste are Ignitability, Corrosivity, Reactivity, which comprise (D001 – D003), as well as Toxicity, which constitutes the remaining listings (D004 – D043)

#8 – How are healthcare facilities different than industrial facilities?

There are a few fundamental differences between the types of hazardous waste generated by healthcare facilities, and the processes by which it is generated:

  • Healthcare facilities, by virtue of their nature, generate a wide variety of individual wastes (e.g. different medications), in small amounts (often milligrams), at a large variety of locations (e.g. a hospital room).
  • Industrial waste is often generated as a small number of individual streams, in massive quantities, at a small number of collection points.

#9 – Why does this mean new rules are required?

Due to the differences stated above, the current regulations applying to hazardous waste are not suited for healthcare providers and create an untenable and complicated waste management system for persons who have to work with their stipulations. The main concerns were:

  • Waste determination
  • Generator status resulting from acutely hazardous waste
  • Hazardous waste listings
  • Accumulation time limits

Because of these issues of complexity, environmental impact, and illicit potential, this new set of regulations has been implemented. Hopefully, it provides a streamlined, vigilant, and sustainable framework for healthcare facilities to manage their hazardous pharmaceutical waste disposal.

#10 – So, how are things different?

The most impactful differences enacted by the new ruling are a series of exemptions and extensions pertaining to healthcare facilities and their related entities.

  • Healthcare facilities will not (1) become large quantity generators after producing more than 1 kilogram of acutely hazardous waste in a single month, (2) be required to follow satellite accumulation area laws, and (3) be required to assign hazardous waste codes on manifests.
  • Healthcare facilities will (1) be allowed to store hazardous pharmaceutical waste disposal on site without a RCRA permit for one calendar year (365 days), and (2) have basic training requirements.

#11 – What about OTC nicotine replacement therapies?

OTC nicotine replacement therapies are exempted under this new legislature, and may be disposed of as non-hazardous waste

#12 – When does this start?

Besides the immediate ban on flushing hazardous pharmaceutical waste disposal, the ruling will become law six months after its publication date in the Federal Register. According to our math whizzes here at HTS, that date should be Wednesday, September 18th (180 days after publication).

Hopefully, this bite-sized list provided you some insight into the upcoming changes taking place in the world of hazardous waste management. If you would like to see the ruling in all its bureaucratic glory, the original document can be found here.

Our outstanding team at HTS is committed to service, including hazardous waste transportation and support. We are here to help with and all compliance issues or assorted inquiries. Don’t hesitate to contact us online or give us a call for assistance!


References:

  1. https://www.federalregister.gov/documents/2019/02/22/2019-01298/management-standards-for-hazardous-waste-pharmaceuticals-and-amendment-to-the-p075-listing-for
  2. https://blog.sharpsinc.com/hazardous-drugs-vs-hazardous-waste-pharmaceuticals
  3. https://www.healthcarelawtoday.com/2019/01/09/medication-or-hazardous-waste-epa-creates-significant-new-requirements-for-managing-unused-pharmaceuticals/
  4. https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and