How to Identify and Dispose of Hazardous Pharmaceuticals and Controlled Substances

Written by Benjamin Mandel

November 8, 2021

Knowing which drugs need to be disposed of in hazardous waste containers is vital. Compliance with federal and state regulations reduces the potential for fines and penalties while at the same time increasing safety. Proper management, protocols, and in-house processes for any facility that handles or receives hazardous drugs also protects human health and the environment.

How are hazardous drugs defined?

According to the Environmental Protection Agency, hazardous waste is defined as “a waste with properties that make it dangerous or capable of having a harmful effect on human health or the environment.” Rather than regulate individual medications, the EPA regulates hazardous characteristics and chemicals under the Resource Conservation and Recovery Act (RCRA). When a medication exhibits or containers a listed chemical, it must be managed in accordinace with the regulations.

RCRA hazardous pharmaceuticals found in the listings tend to be toxic in nature, or acutely hazardous if it has the potential to be fatal to animals or humans even at a low dose. Such drugs can also pose “substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, or disposed of, or otherwise managed” according to 40 CFR §261.11(a)(3), the federal regulations that empower the EPA to regulate hazardous waste.[2]

Such drugs are found in a wide variety of facilities, including pharmacies, veterinary practices, hospitals, outpatient centers, cancer clinics, and research laboratories, among others. It’s not just the healthcare providers who might be exposed to such drugs, but ancillary staff, including EVS professionals, in addition to hazardous medical waste company transporters as well as those who receive such waste at a waste treatment facility.

A complete listing of hazardous drugs is too broad to include within this article, but there are several resources available to assist in determining whether your facility has RCRA hazardous medications:

EPA definition of characteristic wastes. The EPA has identified four characteristics of hazardous waste that, when present, pose a sufficient threat to human health or the environment. These are ignitability, corrosivity, reactivity, and toxicity found in 40 CFR §261.21 – §261.24.
P- and U-listings of regulated chemical compounds that are identified as hazardous by the Environmental Protection Agency (EPA) and can also be found in the Code of Federal Regulations (40 CFR §261.33(e) and 40 CFR §261.33(f)). The Resource Conservation and Recovery Act (RCRA) regulates the management of all hazardous waste in the United States.
The Healthcare Environmental Resource Center (HERC) also provides listings of common hazardous pharmaceuticals along with common P- and U-listed waste.

Mixed radioactive hazardous waste generated from cancer therapies or other procedures should also be carefully segregated, handled, and disposed of accordingly. Refer to the EPA or your state environmental agency for compliant storage, transportation, and treatment of such waste, even if it is transported off-site.

Common drugs that require disposal in hazardous waste containers

Important determinations need to be made regarding common drugs that require disposal in hazardous waste containers by referring to RCRA listed wastes.[3] For example, common P-listed, U-listed, and chemotherapy pharmaceuticals include but are not limited to:

Warfarin
Coumadin
Physostigmine
Arsenic trioxide
Epinephrine (in some )

A number of U-listed pharmaceuticals include:

Chlorambucil (a chemotherapy drug)
Lindane Cyclophosphamide (a chemotherapy drug)
Mitomycin Reserpine
Phenol
Daunorubicin Selenium Sulfide Shampoos (Selsun Blue)

Chemotherapy drugs have the potential to be extremely toxic and are often listed in one or both of the U or P lists. However, chemotherapy agents are frequently listed by brand or manufacturer name, generic name, or chemical designations. Refer to listings frequently as new products are introduced into the market on a continual basis. Some of the more common chemotherapy agents by brand include but are not limited to:

Melphalan
Leukeran
Cytotoxan
Trisenox
Arsenic trioxide

Because of their toxic nature, most chemotherapy agents must be treated, handled, and disposed of as a hazardous waste. Appropriate disposal in recognizable and clearly marked hazardous waste containers is essential for safety as well as where that waste ends up.

Considerations for controlled substances

While the EPA in combination with state and local agencies regulate the disposal of hazardous waste under RCRA, the Drug Enforcement Administration (DEA) maintains authority on the controlled substance regulation. In addition to knowing which drugs are hazardous, you must also be able to identify controlled substances and follow through on additional disposal requirements that may apply.

They key additional requirement is that controlled substances must be rendered “non-retrievable” as part of the disposal process. The goal of rendering drugs “non-retrievable” is to ensure that controlled substances are altered so that they are “unavailable and unusable for all practical purposes …[to] prevent diversion of any such substance to illicit purposes” (21 CFR §1300.05).[4]

Importantly, the DEA does not specify an exact method of destruction to render drugs non-retrievable, instead emphasizing that “the method of destruction shall be sufficient to render all such controlled substances non-retrievable” (21 CFR §1317.90).[5] However, they do specify oversight procedures for on-site destruction at registered facilities (most healthcare facilities), requiring two employees to handle and witness the process.

Disposal for Controlled Substances

When determining how to dispose of controlled substances, an identification must first be made on whether the controlled substance to be disposed of falls under the category of “inventory” or “wastage.” The DEA makes a clear distinction on the expected procedures and record-keeping for controlled substance disposal under the Controlled Substances Act (CSA) found in 21 CFR § 1304.21. The DEA is clear that these rules do not apply to controlled substance wastage, defined as “a controlled substance dispensed for immediate administration pursuant to an order for medication in an institutional setting” and is not fully exhausted.[6]

Disposal requirements for on-site drug wastage destruction – non-retrievability and witnessing/documentation – are broad enough as to allow for some flexibility with how your facility chooses to go about it. However, there are some methods that are more effective than others, especially when dealing with a variety of controlled substances with different chemical make-ups.

There are many ways to absorb and chemically alter pharmaceuticals to denature them and make them non-retrievable; however, not all solutions are created equally. Secure a Drug, for example, utilizes a simple solution of warm water and activated charcoal to denature, dissolve, and neutralize pharmaceuticals in a manner that promotes safety for patients, clinicians, and the public alike.

The best part of a solution like Secure a Drug is that once the substances are denatured and non-retrievable, the entire container can be picked up by your waste disposal partner and disposed of in compliance with state and federal regulations.

Drug Disposal Safety Is Key

We are dedicated to providing resources and solutions for compliant and cost-effective disposal of hazardous pharmaceuticals and controlled substances. For more information regarding compatible and compliant containers in various sizes and designs for hospital, clinical, or other producers, contact one of our representatives today.

[1] https://www.epa.gov/hw/learn-basics-hazardous-waste

[2] https://www.ecfr.gov/current/title-40/chapter-I/subchapter-I/part-261/subpart-B/section-261.11

[3] https://www.hercenter.org/hazmat/pharma.php

[4] https://www.ecfr.gov/current/title-21/chapter-II/part-1300/section-1300.05

[5] https://www.ecfr.gov/current/title-21/part-1317/subpart-C

[6] https://www.federalregister.gov/documents/2014/09/09/2014-20926/disposal-of-controlled-substances