Wiki Archive for Dangerous Prescription Drugs Information Compilation
The Resource Conservation and Recovery Act (RCRA) hazardous waste regulations have been amended to exclude FDA-approved over-the-counter nicotine replacement therapies (NRTs) from the P075 listing. This amendment, finalized on February 22, 2019, was outlined in the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing.
This means that products like nicotine gums, patches, and lozenges are not specifically listed as hazardous waste at the federal level. The P075 listing primarily targets nicotine wastes from manufacturing processes, not finished consumer OTC NRT products. Concentrated nicotine wastes from manufacturing or research processes, however, are regulated as acutely hazardous waste.
Post-consumer products, on the other hand, are generally not regulated as hazardous waste unless contaminated or disposed of in large quantities. Some states may have additional provisions regarding nicotine-containing wastes, but in general, OTC NRTs are considered pharmaceutical waste or consumer product waste, not federally regulated hazardous waste under P075.
It is important to note that electronic nicotine delivery systems and some nicotine-containing vaping products are regulated and have specific disposal recommendations due to batteries and potential toxic components. These are distinct from OTC NRTs.
The Hazardous Waste Pharmaceuticals Wikispace website, an informational platform sponsored by the Environmental Protection Agency (EPA), aimed to facilitate collaboration among healthcare professionals and stakeholders. The goal was to determine whether specific pharmaceuticals meet the RCRA definition of hazardous waste when discarded. However, it is crucial to note that the views expressed on the platform do not reflect EPA policy, action, or the official views of EPA or the federal government.
The website was an invaluable resource, providing item-specific information and sharing state-specific regulations. Before the website was shut down in September 2018, EPA downloaded and preserved the relevant information. The content was generated by registered users.
However, it is essential to check with your state environmental agency to determine if FDA-approved over-the-counter nicotine replacement therapies continue to be considered acute hazardous waste in your state, as authorized states are not required to adopt the nicotine amendment.
In summary, following the 2019 amendment to the P075 listing, FDA-approved OTC NRTs remain outside the scope of federally regulated hazardous waste listings for nicotine under RCRA. Disposal guidelines at the state level may vary but do not usually categorize these therapies as hazardous waste.
- In light of the 2019 amendment to the P075 listing, FDA-approved over-the-counter nicotine replacement therapies (NRTs) like nicotine gums, patches, and lozenges, are not classified as hazardous waste at the federal level, but disposal guidelines at the state level may vary and do not typically categorize these therapies as hazardous waste.
- The amendment clarifies that OTC NRTs are not specifically listed as hazardous waste at the federal level, and instead, they are usually considered pharmaceutical waste or consumer product waste, while the environmental science of waste management focuses on controlling and reducing the harmful effects of other waste materials on health-and-wellness and the environmental-science.
