Pharmaceutical waste is any expired prescriptions, unused or surplus medications that can no longer be used, are no longer needed, or cannot be sold or prescribed. Pharmaceutical waste must be classified and segregated as either hazardous or non-hazardous waste which is dependent upon the characteristics of the pharmaceuticals and the risk they pose to the environment and to humans. A drug’s physical, toxicological, and chemical characteristics are assessed to determine the right classification.
If a pharmaceutical company generates highly reactive waste, such as diazo and azo compounds or perchlorates, that waste requires specific handling and should be classified as hazardous. Generators of pharmaceutical waste must know which category their hazardous waste belongs in for safe drug waste disposal.
Hazardous Pharmaceutical Waste
Characteristics that are commonly associated with hazardous pharmaceutical waste include reactivity, corrosivity, the presence of heavy metals and ignitability. Some commercial medications and pharmaceuticals are also considered hazardous based on their identification on the P and U lists generated by the Environmental Protection Agency (EPA). Hazardous pharmaceutical waste includes nitroglycerin, epinephrine, nicotine and more. The following criteria must be met to define hazardous pharmaceutical waste:
- At least one chemical in the waste must be on the P or U list
- The chemical in the waste must be in the form of a commercial chemical product
- The chemical must be unused
The EPA’s final rule issued in 2019 regulates hazardous waste pharmaceutical disposal for healthcare institutions, and is known as Subpart P. Subpart P provides direction to healthcare institutions on managing hazardous pharmaceutical waste while protecting the environment and public health.
Non-Hazardous Pharmaceutical Waste
When households generate pharmaceutical waste it is considered to be Very Small Quantity Generators (VSQGs) which are considered to be non-hazardous.
Achieving Compliance by Pharmaceutical Waste Companies
Companies that generate more than 100 kg of waste identified as RCRA (Resource Conservation and Recovery Act) Waste must handle it as hazardous waste. The waste generator is responsible for determining if the pharmaceutical waste should be considered RCRA waste or not.
Pharmaceutical Waste Disposal and Environmental Considerations
Pharmaceutical waste can leach into the soil and natural water sources, polluting plants, animals, and humans. Medications such as antibiotics that get absorbed into water sources can affect the drinking water supply as well as local wildlife. Federal regulations such as the Code of Federal Regulations, EPA 40 CFR, are aimed at reducing the impact of pharmaceutical waste on our ecology.
In addition to EPA regulations, disposal of controlled substances must be in compliance with the Drug Enforcement Administration’s regulations outlined in DEA 21 CFR. Generators of pharmaceutical waste must meet both EPA and DEA regulations, in addition to any local, state, or tribal regulations as well as facility specific procedures.
Rx Destroyer: An Important Part of Pharmaceutical Waste Disposal
Rx Destroyer™ is an important part of pharmaceutical waste disposal policies, providing facilities and pharmacies a quick and easy method to dispose of medication waste. The patented* formula begins to quickly neutralize medications on contact to render them non-retrievable through chemical digestion. Chemical digestion is a DEA approved method of drug destruction meeting 21 CFR requirements.
C2R Global Manufacturing is the manufacturer of Rx Destroyer™, a safe and easy to use drug disposal system. Rx Destroyer™ is available in a wide range of product sizes with features such as lock boxes and tethered caps. Contact us to request a free sample and see how easy it is to properly dispose of pharmaceutical waste and protect the environment.