Pharmaceutical waste can be classified as non-hazardous, hazardous, or medical waste. To determine into which category a pharmaceutical waste falls, its chemical, physical, and toxicological characteristics are assessed and classified. For example, if a pharmaceutical company generates highly reactive waste (e.g. perchlorates, diazo and azo compounds), it is classified as hazardous waste and requires specific handling. To ensure compliance with federal regulations, generators need to know into which category their hazardous waste falls.
Hazardous Pharmaceutical Wastes
Pharmaceutical waste is any surplus, unused, or expired pharmaceuticals that are no longer needed or can no longer be used or sold. Pharmaceutical waste can be classified as hazardous or non-hazardous depending on its associated hazards and its risk to humans and the environment. Common hazardous characteristics include ignitability, corrosivity, reactivity, or the presence of certain heavy metals. Some unused commercial pharmaceuticals are also hazardous wastes based on their presence on the P and U lists. This includes chemicals that are no longer needed, are expired or off-specification, or spill residues. Listed hazardous pharmaceutical wastes include nicotine, epinephrine, nitroglycerin, and more. For a waste to be listed, it must meet the following criteria:
- The waste must contain one of the chemicals on the P or U list
- The chemical in the waste must be unused
- The chemical in the waste must be in the form of a commercial chemical product
Non-Hazardous Pharmaceutical Wastes
Pharmaceutical wastes from households and certain quantity generators, known as Very Small Quantity Generators (VSQGs), are qualified as non-hazardous.
How Pharmaceutical Companies Can Achieve Compliance
Businesses generating over 100 kg per month of RCRA regulated hazardous pharmaceutical waste are required to manage it as hazardous waste. Generators are responsible for determining whether their pharmaceutical wastes are considered to be RCRA hazardous wastes. Because these various hazardous waste regulations can be difficult to keep up with, it is helpful to consult with hazardous waste specialists who can evaluate your existing waste and disposal operations.
Environmental Considerations
Without proper regulations and control, medical waste can make its way into water sources and soil, affecting local humans, plants, and animals. Additionally, contaminated sharps can create unnecessary risk in your facility for patients and employees, while products such as antibiotics can be absorbed within water sources, affecting local wildlife in addition to drinking supply. Growing global efforts have been made to reduce the impact of medications on our ecology, which is why Triumvirate focuses on delivering the safest solutions.
EPA’s Final Rule
The Environmental Protection Agency (EPA) issued a new rule in 2019 regulating the disposal of hazardous waste pharmaceuticals for healthcare institutions. The law, known as Subpart P, is intended to provide direction for how healthcare institutions manage hazardous waste pharmaceuticals while still protecting public health and the environment. Subpart P covers the following relevant topics:
- Both Small and Large Quantity Generators of hazardous pharmaceutical waste must manage their waste under new Subpart P
- VSQGs that are defined as healthcare facilities or reverse distributors under Subpart P have the option to manage hazardous waste pharmaceuticals under new Subpart P as the rule is optional for generators at this level
- Increased disposal options for containers containing residual hazardous waste and P-listed wastes
- Controlled substances that are hazardous waste are conditionally exempted from being managed as such when they are managed in compliance with DEA regulations and incinerated at an authorized facility
Amendment to the P075 Listing for Nicotine
Additionally, under this final rule, FDA-approved, over-the-counter nicotine products (i.e., nicotine patches, gums, and lozenges) will no longer be considered hazardous waste when discarded. While many states have fully adopted this rule (AK, AZ, CO, DE, GA, IL, IN, OH, PA, NJ, FL, SD, UT, IA, NC), some states have adopted only the nicotine exemption while the states review Subpart P (NH, MN, NY, CA). Many states are currently reviewing for partial or complete adoption this year or in early 2022 (AR, DC, HI, ID, MS, MT, MO, NY, NH, RI).
Triumvirate is here to deliver hazardous pharmaceutical waste disposal and support services, relying on our expertise and top-notch equipment to ensure your facility is optimally prepared for success. Click below to learn more about our services for DEA waste management.
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