What Is Pharmaceutical Waste?
Whether you operate a pharmacy, an outpatient center, a cancer center, an independent physician’s practice, or a hospital, proper pharmaceutical waste management is essential. As part of the pharmaceutical waste management processes, healthcare professionals are required to be able to classify categories of pharmaceuticals as defined by the Environmental Protection Agency (EPA), particularly, distinguishing between hazardous and non-hazardous pharmaceuticals.
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1 / Pharmaceutical waste definition
4 / Choose Daniels Health for compliant pharmaceutical waste management
Pharmaceutical waste definition
Pharmaceutical waste is generally defined as any medicine or drug that may be expired, unused, or left over after medical treatment or surgical procedure. It also includes drugs that have been prescribed to patients, which also must be properly disposed of. Pharmaceuticals can include prescription drugs as well as over-the-counter medications. In fact, sharps and diabetic test strips can also be considered a pharmaceutical waste.
Pharmaceutical waste examples
Pharmaceutical waste can include but is not limited to:
- Some dietary supplements and over-the-counter drugs
- Compound drugs
- Prescription drugs
- Some homeopathic drugs
Why Proper Disposal Matters
Special handling is required of pharmaceutical waste because of its potential threat to the environment, human safety and health. This is due to the chemicals and components found in many pharmaceuticals and drugs, whether they are over-the-counter or prescribed. Pharmaceuticals may not be “dumped” in sewers or flushed down toilets or drains.
State-Specific Pharmaceutical Waste Classifications
In some states, the classification of pharmaceutical waste can differ slightly from others. For example, in the state of Minnesota, pharmaceutical wastes are considered hazardous waste unless they have been evaluated and determined by the waste generator as being non-hazardous. Other states may have similar specifications in regard to handling and disposal.
Federal Pharmaceutical Waste Regulations
At the federal level, the Resource Conservation and Recovery Act (RCRA), defines a number pharmaceuticals regulated as hazardous waste. It’s important to note that these definitions can also overlap with those of the Drug Enforcement Agency’s listing of controlled substances. Among them include phenobarbital and testosterone gels.
However, keep in mind that hazardous waste pharmaceuticals that also happen to fall under DEA controlled substances must be disposed of in a compliant manner and in accordance with DEA regulations, such as incineration with an approved and compliant hazardous waste incinerator facility.
Several other agencies and their regulations are also involved in regulating hazardous pharmaceutical waste, including the Department of Transportation (DOT), the Occupational Safety and Health Administration (OSHA), and the Clean Water Act.
How to distinguish between pharmaceutical hazardous waste and non-hazardous pharmaceutical waste
Understanding the difference between pharmaceutical hazardous waste and non-hazardous pharmaceutical waste is crucial for proper disposal and compliance with regulations. Here’s how:
Identifying Hazardous Pharmaceutical Waste
The Environmental Protection Agency (EPA) provides guidelines for identifying hazardous pharmaceutical waste based on its listings and characteristics. Detailed information on such identification can be found here.
A pharmaceutical is considered hazardous if:
- It exhibits characteristics such as:
- Toxicity
- Corrosivity
- Ignitability
- Reactivity
Some states also include oxidizers and lethality in their hazardous-waste characteristic definitions. Chemotherapy wastes are typically defined as hazardous due to their components.
2. The chemical name of a waste or the ingredients of a pharmaceutical can be found in the F, K, P, or U-lists maintained by the EPA
In the healthcare industry, the P- and U-listed hazardous wastes are typically found in commercial grade formulations
- P-listed items typically identify acute hazardous waste, such as discarded commercial chemical products.
- U-listed wastes usually represent hazardous wastes from discarded commercial chemical products, commonly found in pharmaceuticals.
Determining Non-Hazardous Pharmaceutical Waste
Non-hazardous pharmaceutical waste includes drugs that do not meet the criteria for hazardous classification. These might still require careful disposal to prevent environmental harm but do not contain the toxic, reactive, or corrosive properties that define hazardous waste.
Resources
Many states throughout the country provide a specific list of hazardous waste pharmaceuticals. For example, Florida provides a PDF file of hazardous-waste pharmaceuticals. However, it is the generator’s responsibility to determine ultimate identification.
In addition to lists of pharmaceutical drugs and waste processes of the EPA and the RCRA, the Healthcare Environmental Resource Center also provides information regarding pharmaceuticals, hazardous determinations, and disposal of hazardous pharmaceutical wastes. It is important for the waste generator to understand that some pharmaceuticals are more toxic than others, such as chemotherapy drugs, otherwise known as antineoplastic agents.
Preservatives in some drug preparations or their ingredients might pose toxicity hazards over and above their main active ingredient. Some can be corrosive or even radioactive, as again in the case of certain chemotherapy drugs or agents including tracers or markers.
Keep in mind that regulations and handling and disposal processes may differ slightly from state to state. For specific state requirements, start here.
About chemotherapy waste
Chemotherapy waste must be handled carefully due to its potential for harming cellular structures. RCRA guidelines provide valuable information regarding the identification and classification of such waste. Additional information about hazardous wastes guidelines for special pharmaceutical wastes such as chemotherapy waste can be found under the Code of Federal Regulations Title 40.
Types of Chemotherapy Waste
- Trace Chemotherapy Waste:
- Includes IV tubing, bags, and vials of a chemotherapy drug.
- Note that vials or containers that contain a substance associated with the U-listed drug list can be defined as “empty” if residues amount to less than 3% (see section 261.7, CFR title 40).
2. Bulk Chemotherapy Waste:
- Non-empty containers of chemotherapy drugs that still hold 3% or more by weight of the original capacity
- Includes visibly contaminated personal protective equipment.
- Full bottles, vials, or bags that contain a P-listed chemotherapy drug are also defined as bulk chemotherapy waste.
Specific guidelines can be found under title 40 CFR, Part 262 regarding packaging, labeling, and marking of chemotherapy waste and are applicable to all generators of such waste.
Chemotherapy waste can be incinerated, but if it is transported off-site, it must be segregated into a compliant container that meets DOT guidelines at its point of origin and before transportation. Hazardous waste manifests must also be filled out and carried along with the shipment.
Choose Daniels Health for compliant pharmaceutical waste management
Accurate identification, segregation, and disposal of pharmaceutical drugs are essential not only for protection of human health, but the environment. Regardless of type or size of facility, any entity that utilizes, dispenses, or deals with pharmaceuticals and their waste must ensure compliance in regard to handling and disposal.
Daniels Health provides resources and support to any facility that deals with pharmaceutical waste, promoting the cradle-to-grave approach. Compliant pharmaceutical waste management is not simply ethical, but it’s the law. For more information on how we can help you with your pharmaceutical waste management, contact us today.
Amy Piser
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