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Pharmaceutical Waste Disposal

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Pharmaceutical Waste Disposal

In today’s healthcare landscape we are seeing the addition of several products that are considered to be medications and may contain elements that are dangerous, and yet are not caught by the categories established by the CDC (Center for Disease Control and Prevention). This condition is expected to continue to expand as science and technology brings more products to market. Although regulations have been established in the handling and disposal of hazardous pharmaceutical wastes, the dichotomy is that those same regulations have received little in the way of updates since they were created in 1976. It is believed that around 10% of the drugs and over-the-counter products that are in use today are not labeled as be hazardous waste even though they share the characteristics defined as hazardous waste. Regulations regarding pharmaceutical waste disposal are complex and each state may have different guidelines for compliance. For any concerns or questions contact Healthcare Waste Management our professional staff is knowledgeable about the states that we service.

History of Controlling Medical Waste Disposal

Considering that medical waste has been around for hundreds of years and was mostly just thrown in with other types of wastes, it is surprising that it took the U.S. government as long as it did to define and regulate medical waste. Previous laws had been established such as the River and Harbor Act of 1886 for the protection of water resources, but it took until 1965 for Congress to pass the Solid Waste Disposal Act (SWDA), a first attempt at controlling the management of solid waste on a comprehensive level. It was not until medical waste began to show up on the shores of some of the East Coast beaches in 1976 that the government instituted the RCRA (Resource Conservation and Recovery Act).

The initial implementation of the RCRA was given to the Environmental and Protection Agency (EPA) as they designed medical waste management and disposal programs designed for the protection of the environment, the conservation of resources, the reduction of the amount of generated waste, and the protection of people from the dangers of potentially transmitted diseases. In 2015, the addition of subtitle C to RCRA identified solid and hazardous wastes, established criteria for hazardous waste generator types, created standards for those that were responsible for the transportation of hazardous waste, and established standards for the disposal facilities for hazardous wastes. These responsibilities were later given to each individual state. In some cases states incorporated additional laws for compliance.

The 2015 Subtitle C focused on the topic of hazardous waste; however, it did not address hazardous wastes generated from pharmacies, hospitals, health clinics, and reverse distributors. It took the addition of 40 CFR Part 266, subpart P in 2019 to establish standards for the management of specific hazardous waste and its disposal to include pharmacy regulations for any pharmacy hazardous waste generator. A code of regulations for specific hazardous waste generators is found at 40 CFR Part 262.

Why Change is Needed

While the RCRA was initially applauded as a landmark ruling, the law has not changed to keep up with medical and scientific advances. We now have an incredible volume of new and innovative drugs, drug therapies, over-the-counter medications, supplements, and products such as patches that are not included as part of the hazardous pharmaceutical waste definition, even though they have some of the characteristics of hazardous waste. It’s estimated that 5-10% of the pharmaceutical products today are classified as hazardous and there is a requirement for the government to revisit the RCRA for the purposes of evaluating and classifying the medical waste that should be listed as hazardous.

Compliance with state and federal laws are the responsibility of the generator of the hazardous waste as well as those that transport and the facilities that render them harmless. Lack of compliance can result in high financial fines. There is a requirement for more in-depth clarification of the definitions of pharmaceutical medical waste and the addition of products currently left out of the hazardous classification.

The regulations established by the EPA for management of hazardous waste pharmaceuticals have two criteria:

Pharmaceutical listed as non-regulated, non-hazardous do not carry the requirement of being transported as hazardous waste.

A hazardous waste manifest is required for the shipment of pharmaceuticals listed as hazardous and they must be sent to a facility listed as RCRA permitted.

What is Pharmaceutical Medical Waste?

Pharmaceutical waste has been defined as: any chemical or biological product medicine that is intended for use in the diagnoses, care, cure, mitigation, treatment or prevention of injury or disease of a human or other animal. The waste can include any unused, expired, or leftover medication that cannot be used.  In addition to federal laws, each state has created their own guidelines for infectious waste, chemotherapy waste, sharps, and disposal procedures. Pharmaceutical waste is classified as non-hazardous or hazardous, depending upon the risk to humans and the environment and its individual chemical composition. 

Pharmaceutical medical waste that is defined as hazardous is divided into three categories:

P-list: any drug or medication that is considered hazardous, including remnants and packaging for those drugs.

U-list: relates to any drug associated with chemotherapy.

Characteristic hazardous waste is any waste that hasn’t been included in the P- or U- listed categories but may include one or more of the four characteristics defined as hazardous waste. Characteristic hazardous waste managed as hazardous waste as defined by RCRA.

The four characteristic types of pharmaceutical hazardous waste:

Any medication, drug, or over-the-counter product that exhibits any of the pharmaceutical hazardous waste characteristics but may or may not be defined as hazardous waste is hazardous waste.

The four characteristics include:

Ignitability: If the product waste type is flammable or has an easily achievable flashpoint that can cause it to ignite.

Corrosiveness: This is defined using the product’s pH and the category can includes bases and acids.

Reactiveness: This is a case where the pharmaceutical waste can interact with other chemicals in a negative was to cause an explosion or the generation of toxic fumes or gases. There isn’t any defined testing process for the determination of the reactivity of a substance. There has been a  Safety Data Sheet created that is associated with specific drugs to recognize whether or not a drug falls into this specific category.

Toxicity: The EPA has designated only certain chemicals under the toxic category for waste. The designation is based on the concentration amounts of these chemicals. Determination of toxicity is based on using the Toxicity Characteristics Leaching Procedure (TCLP).

Disposing of Pharmaceutical Waste

Correct methods of disposal for pharmaceutical waste depends upon the type of waste. The guidelines for disposal have been established by the EPA and DEA, however, states may vary in the ultimate methods of destruction.

Pharmaceutical waste can include hazardous and nonhazardous. However, even over-the-counter medications can contain ingredients that could harm the environment if placed into a landfill. Both types of pharmaceutical wastes can be in the forms of liquid or solid waste. The EPA has established the Land Disposal Restriction in which pharmaceuticals are required to be treated before they are disposed of.

Importance of a Professional Waste Disposal Company

Given the incredible volume of laws and compliance regulations, having a licensed, trained, and professional medical waste disposal company is a priority for compliance. Since all of the responsibility of being compliant falls on the generator, it means that consequences for disobeying a law can result in high fines and potential closure of the organization. There are often both state and federal audits levied on a company that generates pharmaceutical medical waste and they rely on the manifests and documentation supplied by a good medical waste disposal company such as  Healthcare Waste Management.

A professional medical waste company will act as a consultant to review the location, offer specific local and state regulation information, make recommendations on such topics as storage areas, supply FDA-approved pharmaceutical medical waste containers, and offer OSHA-approved employee training and certification. The better medical waste disposal companies such as Healthcare Waste Management will have all staff employed by the company, own their own vehicles, trucks, and the facilities for waste destruction.

A licensed and experience medical waste disposal company will make sure that an organization doesn’t suffer the consequences of improper pharmaceutical waste disposal such as:

Financial Consequences of Non-Compliance

In addition to the damages that can occur from non-compliance of proper pharmaceutical medical waste disposal, there can be financial costs that can be crippling. Both the state and federal agencies can levy high fines for any area of non-compliance. Over the last few years the various agencies governing proper medical waste disposal has increased both the number of audits and the amounts configured in the fines assessed for noncompliance.

The violations can encompass everything from failure of proper identification of hazardous waste to failure to provide and/or require proper staff training that abides by the OSHA requirements.

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