Opinion Piece: EPA’s Final Rule on Management of Hazardous Waste Pharmaceuticals

By Mark Fulton

 

A recent article in Drug Topics discussed the Environmental Protection Agency (EPA)’s new rule for disposing of hazardous pharmaceutical waste.

Some of our customers have contacted SoftWriters about our point of view on this rule, inspiring us to dig deeper into this topic.

In this article, we’ll break down some of the most important features of the rule and share our perspective on some key items that long term care pharmacies should keep in mind.  

What are “Hazardous Waste Pharmaceuticals”?  

Firstly, it’s important to understand how we classify “hazardous waste pharmaceuticals”.

Hazardous waste pharmaceuticals are drug wastes that are classified as hazardous because they contain one or more of the components listed in Appendix VIII to section 261 of Title 40 in the Code of Federal Regulations.

For example; selenium, chromium and warfarin are on this list.

However, it is important to note that pharmaceuticals that are, or have a reasonable expectation to be, reused or reclaimed are NOT considered hazardous waste.

The New Rule

The reason that the EPA published this regulation perhaps lies in the key differences between healthcare facilities and industrial hazardous waste generators, such as chemical manufacturing plants.

 In an industrial setting, an entity typically generates large volumes of a small number of waste types in a singular location.

In a healthcare system, however, entities such as pharmacies, nursing stations and operating rooms generate small volumes of many types of hazardous waste in many different locations. 

Because of these inherent differences, regulations that work well for industry are not easily applicable to healthcare settings.

This new EPA regulation concerns specific issues regarding the generation, storage, and disposal of pharmaceutical hazardous waste in healthcare settings.

It creates and reaffirms definitions of terminology, such as “hazardous pharmaceutical waste” and “healthcare facility”.  

It also removes regulatory overlap of pharmaceutical wastes that are also controlled substances. These products should be disposed of according to the DEA guidelines. This is not new, but merely a clarification.

Effective August 21, 2019, the disposal of hazardous waste pharmaceuticals into the sewer system is explicitly and completely prohibited in all states. This includes flushing in a toilet or dumping down the sink, to protect the environment and the safety of the water supply.

OTC Nicotine No Longer Considered Hazardous Waste

The EPA rule also clarifies that over-the-counter nicotine products (patches, gum, etc.) are no longer considered hazardous waste.

This becomes effective August 21, 2019 in Iowa and Alaska, and becomes effective in all other states after the adoption of Subpart P.  

Storage and Shipment of Hazardous Pharmaceutical Waste

Subpart P of the EPA’s Final Rule is specific to healthcare facilities and reverse distributors. This section deals with defining hazardous pharmaceutical waste and specifying how it can be stored and shipped.

  • Pharmacies may treat all pharmaceutical wastes as hazardous and accumulate all pharmaceutical waste in the same container. Conversely, a pharmacy may determine if a waste is hazardous and store hazardous and non-hazardous waste separately.

  • If the pharmaceutical waste is potentially creditable (i.e. un-dispensed, expired for less than one year, recalled), it is sent to a reverse distributor for manufacturer credit.
    Reverse distribution refers to the movement of prescription pharmaceuticals that are not intended to be resold or reused. After processing, the waste is sent to a Treatment, Storage and Disposal Facility (TSDF). Potentially creditable hazardous pharmaceutical waste can be stored onsite indefinitely and can be shipped to the reverse distributor via common carrier (for example, UPS or FedEx).

  • Non-creditable pharmaceutical waste includes products that are unusable, damaged, expired for more than one year, and are otherwise not eligible for manufacturer credit. They can be stored onsite for up to 1 year and must be shipped to a TSDF by a hazardous waste transporter, such as Stericycle.

 

Subpart P becomes effective once it is adopted by the state legislature but must be adopted no later than July 1, 2021 (in states that do not require a legislative session) or July 1, 2022 (in states that require a legislative session).

 

It is worth noting that this law affects how hazardous pharmaceutical waste is stored and disposed. It ensures that the water system remains safe by formally prohibiting the disposal of pharmaceutical hazardous waste into the sewer system.

It does not affect how prescriptions are processed, billed, dispensed, shipped, and/or returned to stock. As such, in our opinion, this EPA rule does not warrant any additional action from SoftWriters to support it in the FrameworkLTC suite of products.

Learn more

We recommend that customers review the EPA’s final rule on Hazardous Waste Pharmaceuticals to get more information on this topic. We also recommend that customers should contact Stericycle or other waste disposal service for further information on storage and disposal of hazardous pharmaceutical waste.

 

 

Mark Fulton is a Clinical Product Manager at SoftWriters, a Pittsburgh-based company that offers pharmacy management solutions to pharmacies serving the long-term care community. Mark applies his 16 years of pharmacy expertise to the software development process, creating value by building a more efficient linkage between customers and the development channel.